• Research Protocol - A randomized trial of AmBisome monotherapy and combination of AmBisome and miltefosine for the treatment of VL in HIV positive patients in Ethiopia followed by secondary VL prophylactic treatment with pentamidine

      Hailu, Asrat; Diro, Ermias; Kolja, Stille; Ritmeijer, Koert; Yifru, Sisay; van Griensven, Johan; Zijlstra, Ed; Dorlo, Thomas; Addis Ababa University, Addis Ababa, Ethiopia; University of Gondar, Gondar, Ethiopia; Médecins Sans Frontières, London, UK; Médecins Sans Frontières, Amsterdam, The Netherlands; University of Gondar, Gondar, Ethiopia; Institute of Tropical Medicine, Antwerp, Belgium; Drugs for Neglected Diseases initiative, Geneva, Switzerland; Slotervaart Hospital, Amsterdam, The Netherlands (2014-10)
      General Objectives The overall objective of this trial is to identify a safe and effective treatment for VL in HIV coinfected patients. Primary Objective: To evaluate at day 29 assessment the efficacy of a combination regimen of AmBisome® + miltefosine and AmBisome® monotherapy in Ethiopian co-infected HIV + VL patients. Secondary Objectives: 1. To evaluate relapse-free survival at day 390 (after initial cure at day 29 or cure at day 58 after extended treatment). 2. To assess safety of the regimens. Other objectives: 1.To evaluate of viral load and CD4 count in all patients 2. To evaluate the pharmacokinetics of ARV, Ambisome and miltefosine and immune function markers in a subset of patients
    • Research protocol - Addressing water and sanitation needs of displaced women in emergencies

      de Lange, Rink; Fisher, Julie; Fesselet, Jean Francois; Shanks, Leslie; MSF & WEDC Loughborough University, Loughborough, UK; WEDC Loughborough University, Loughborough, UK; MSF-OCA, Amsterdam, The Netherlands; MSF-OCA, Amsterdam, The Netherlands (2014-09)
    • Research Protocol - An Evaluation of False Positive HIV Results due to Testing Errors

      Maparo, Tatenda; Mungofa, Stanley; Bara, Hilda T.; Chirisa, Florence; MSF-OCA; Harare City Council, Harare, Zimbabwe; Harare City Council, Harare, Zimbabwe (2014-06)
      An unacceptably high frequency of false positive HIV test results has been reported in various settings. Given the severity and implications of an HIV+ diagnosis, a false positive result is likely to be psychologically traumatic and may result in inappropriate and potentially harmful treatment. The current HIV testing algorithm being used in Zimbabwe does not include repeat testing for HIV positive results, and it is not currently known whether testing errors are leading to false positive diagnoses at a significant rate. WHO recommends that an additional specimen for testing be collected at some point after the initial diagnosis is made. This procedure aims to rule out possible technical or clerical errors including specimen mislabelling and transcription errors. STUDY OBJECTIVE: To evaluate the number of false positive HIV results due to testing errors, using the WHO retesting recommendations, in 6 clinics in Harare, Zimbabwe.
    • Research Protocol - Assessing barriers and enablers to reproductive health care in Dollo zone, Somali Regional State: a qualitative study

      Stringer, B;; Balayneh, AB;; Bryson, L;; Price, D;; Bil, K;; Farah, A;; Hussein, R; Médecins Sans Frontières, London, UK; The Ethiopian Public Health Institute, Addis Ababa, Ethiopia; Médecins Sans Frontières; Médecins Sans Frontières; Médecins Sans Frontières; Somali Regional Health Bureau; Médecins Sans Frontières (2017-06)
      A deeper understanding of the perspectives, knowledge and awareness of women living in the region with regard to pregnancy and child birth is essential to learn lessons and increase acceptability and effectiveness for reproductive health care services offered in the area. How do women and men perceive the options for reproductive health care? What are the gaps and needs? What are the barriers? And what may facilitate care? In addition, inquiry with adult men with regard to their knowledge and awareness will help analyse the consistency of main findings through gathering opinions and suggestions at community level. This study therefore aims to describe the population’s everyday experiences in Somali Regional State (SRS) by exploring the enablers and barriers women face in accessing reproductive health care. Key objective:  To understand the reasons behind low utilisation of reproductive health care services in SRS from the perspectives of the local population. Secondary objectives:  To identify gaps and barriers for uptake of reproductive health services.  To identify what may help facilitate use of reproductive health services.
    • Research Protocol - Assessing home based treatment and care of MDR-TB patients in northern Uganda

      Horter, Shona; Collins, Beverley; Du Cros, Philipp; Casas, Esther; Amin, Shoaib; Kasozi, Samuel; London School of Hygiene and Tropical Medicine (LSHTM), London, UK; MSF-UK, London, UK; MSF-UK, London, UK; MSF-Holland, Amsterdam, The Netherlands; MSF, Uganda; National TB and Leprosy Programme, Uganda (2014-09)
    • Research Protocol - Cholera and pregnancy in Haiti: description of pregnant patients presenting to MSF OCA cholera treatment centers, September 2011-December 2013.

      Schillberg, Erin; Bryson, Lindsay; Pierre, Grand; Lenglet, Annick; MSF OCA, Haiti; MSF OCA, Haiti; Ministry of Health Haiti (MSPP), Haiti; MSF OCA, Amsterdam, Netherlands (2015-06)
      Principal objective To understand the demographic, clinical and outcome profiles of pregnant patients that presented with cholera infection to Figaro CTC and CRUO CTU between September 2011 and December 2013. Specific objectives 1. To determine the clinical presentation, treatment regimens and outcomes of pregnant patients with cholera seen at Figaro CTC and CRUO CTU between September 2011 and December 2014; 2. To identify factors related to age, clinical presentation or treatment that favour positive outcomes in pregnant patients with cholera presenting to Figaro CTC and CRUO CTU between September 2011 and December 2014; 3. To describe the evolution of patient profiles of pregnant cholera cases at Figaro CTC and CRUO CTU between September 2011 and December 2014 over time; 4. To describe the evolution of patient profiles of pregnant cholera cases at Figaro CTC and CRUO CTU between September 2011 and December 2014 in terms of spatial characteristics. 5. To identify differences in outcomes of patients presenting to a CTC (Figaro CTC) compared to a specialized maternal CTU (CRUO CTU). 6. To identify differences in outcomes after the implementation of new, more aggressive, maternal rehydration guidelines in June 2013.
    • Research Protocol - Effectiveness and safety of a simplified short regimen for Multidrug Resistant Tuberculosis treatment in Manzini Region, Swaziland

      Casas, Esther; Dlamini, Themba; Dietrich, Sebastian; Keus, Kees; Gashu, Tadele; Greig, Jane; Hepple, Pamela; Shanks, Leslie; Médecins Sans Frontières, Operational Center Amsterdam; National TB Program, Ministry of Health, Swaziland; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam (2014-07)
      Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration. Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a relapse free-cure rate of 88%. Several countries in West Africa started implementing similar regimens with similar outcomes. Evidence of effectiveness of this shortened regimen amongst HIV co-infected population is still limited. We propose an observational study to evaluate the effectiveness of a shortened course MDR TB regimen in the high HIV prevalence and high MDR TB prevalence setting of Manzini Region, Swaziland. Main objective To describe outcomes at end of treatment and relapse rate at 1 year and safety following treatment completion of a short course (9-12 month) MDR TB treatment in HIV co-infected patients in programmatic conditions in Manzini region, Swaziland. Secondary objectives 1. To describe sputum smear microscopy and culture conversion rates at 6 months and time to sputum conversion in both: HIV/MDR TB co-infected patients and MDR TB/HIV negative patients. 2. To describe outcomes at end of treatment and relapse after 1 year of treatment completion of MDR TB treatment in HIV negative patients. 3. To describe the adverse events of the treatment regimen in both: HIV/MDR TB co-infected patients and MDR TB/HIV negative patients. 4. To evaluate risk factors for unfavorable outcomes (death, lost-to-follow up and failure) and relapse as a combined cohort. 5. To describe proportion of inhA and katG mutations for H and correlation with DST for high dose at MIC 1.0 mg/ml amongst MDR TB cases and examine whether genetic mutations for H are risk factors for favorable or unfavorable outcomes (including description of outcomes 10 per baseline level of resistance to H), to increase understanding of the role of high dose H in the regimen. 6. To describe the proportion of relapse and re-infection amongst the patients developing TB at 1 year after treatment completion by genotyping. 7. To describe the correlation of smear microscopy with culture to assess the safety of a simplified monitoring with smear microscopy for MDR TB treatment. 8. To describe the rate of resistance amplification amongst patients with outcome failure.
    • Research Protocol - Effectiveness of a simplified short regimen for Multidrug Resistant Tuberculosis treatment in Karakalpakstan, Uzbekistan

      du Cros, Philipp; Atadjan, Khamraev; Mirzagalib, Tillashaikhov; Nargiza, Parpieva; Zinaida, Tigay; Marjan, Sholtaeva; Tleubergen, Abdrasuliev; Betlam, Marttje; Wise, Emily; Ashagre, Teshome; Kuhlin, Johanna; Slyzkyi, Andrii; Taye, Alia; Dietrich, Sebastian; Nyangwa, Bern-Thomas; Greig, Jane; Hepple, Pamela; Cooke, Graham; Herboczek, Krzysztof; Asif, Muhammad; Achar, Jay; Berry, Catherine; Médecins Sans Frontières, Operational Center Amsterdam; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Imperial College London; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam (2014-07)
      Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the MSF programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region. A prospective observational study has been designed. The primary outcome measure is the success rate at the end of treatment, and relapse and re-infection rates during 12 months of follow up after completion of treatment. Secondary outcome measures include rate of adverse events, interim outcomes with sputum smear microscopy and culture conversion rates at 4 and 6 months and time to conversion. Primary objective: To describe outcomes at end of treatment and relapse rate at 1 year following treatment completion of a short course (9-11 month) MDR TB treatment in programmatic conditions in Karakalpakstan, Uzbekistan. Secondary objectives: 1. To describe the adverse events of the treatment regimen 2. To evaluate risk factors for unfavorable outcomes (death, lost-to-follow up and failure) and relapse as a combined cohort. 3. To describe the rate of resistance amplification amongst patients with outcome failure.
    • Research Protocol - Effectiveness of emergency water treatment practices in refugee camps in South Sudan

      Ali, Syed Imran; Ali, Syed Saad; Fesselet, Jean François; University of California-Berkeley, CA, USA; University of Toronto, Toronto, Canada; MSF Amsterdam (2015-06-01)
      To investigate the concentration of residual chlorine in drinking water supplies in refugee camps, South Sudan, March–April 2013.
    • Research Protocol - Effectiveness of nutritional supplementation (RUTF and multi micronutrient) in preventing malnutrition in children 6-59 months with infection (malaria, pneumonia, diarrhoea), a randomized controlled trial in Kaabong Hospital. Karamoja, Uganda

      Salse, Nuria; van der Kam, Saskia; Swarthout, Todd; Matsumoto, Akiko; Kisambu, James; Edyegu, Grace; De Clerk, Veronique; Casademont, Cristian; Palma, Pedro Pablo; Roll, Stephanie; Roddy, Paul; MSF OCBA, Barcelona; MSF OCA, Amsterdam; MSF OCA, Amsterdam; MSF OCBA, Karamoja, Uganda; Ministry of Health, Karamoja, Uganda; Ministry of Health, Karamoja, Uganda; MSF OCBA, Karamoja, Uganda; MSF OCBA, Barcelona; MSF OCBA, Barcelona; Charite University, Berlin; MSF OCBA, Barcelona (2015-07)
      Overall objective: To determine the effectiveness of 14 days supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone concurrently with treatment for diarrhoea, malaria or lower respiratory tract infection (LRTI) in reducing risk of malnutrition and disease. 1. Primary aim: Effectiveness of supplementation with RUTF concurrently with treatment for diarrhoea, malaria or LRTI in reducing incidence of malnutrition 2. Secondary aims: a. Effectiveness of supplementation with a multi-micronutrient powder (MNP) concurrently with treatment for diarrhoea, malaria or LRTI in reducing incidence of malnutrition b. Effectiveness of supplementation with RUTF or MNP on reduction of frequency of diarrhoea, malaria or LRTI c. Explore effectiveness of the supplements in reducing malnutrition and illness in young children and breastfed children
    • Research Protocol - Effectiveness of nutritional supplementation (RUTF and multi micronutrient) in preventing malnutrition in children 6-59 months with infection (malaria, pneumonia, diarrhoea), a randomized controlled trial in Nigeria

      Kam, Saskia van de; Swarthout, T; Froud, Alyson; Shanks, Leslie; Jiya, N; Boele van Hensbroek, M; Gomez Restrepo, C; Roll, S; Tinneman, P; MSF OCA, Amsterdam; MSF OCA, Amsterdam; MSF OCA, Amsterdam; MSF OCA, Amsterdam; Usman Danfodio University Teaching Hospital, Sokoto, Nigeria; Global Health Child Group, EKZ-AMC; MSF OCA, Amsterdam; Charite University, Berlin; Charite University, Berlin (2015-07)
      Overall objective: To determine the effectiveness of 14 days supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone concurrently with treatment for diarrhoea, malaria or lower respiratory tract infection (LRTI) in reducing risk of malnutrition and disease. 1. Primary aim: Effectiveness of supplementation with RUTF concurrently with treatment for diarrhoea, malaria or LRTI in reducing incidence of malnutrition 2. Secondary aims: a. Effectiveness of supplementation with a multi-micronutrient powder (MNP) concurrently with treatment for diarrhoea, malaria or LRTI in reducing incidence of malnutrition b. Effectiveness of supplementation with RUTF or MNP on reduction of frequency of diarrhoea, malaria or LRTI c. Explore effectiveness of the supplements in reducing malnutrition and illness for moderate malnourished, young children and breastfed children
    • Research Protocol - Efficacy of Amodiaquine-Artesunate and Artemether-Lumefantrine for the Treatment of Uncomplicated Childhood Plasmodium falciparum Malaria

      de Wit, Marit; Bil, Karla; Piriou, Erwan; Siddiqui, Ruby; Bahizi Bizoza, Patrick; van Gool, Tom; Woolley, Ian; MSF-OCA; MSF-Holland; MSF-Holland; MSF-UK; Ministry of Health, South Kivu, DRC; Academic Medical Center, Holland; MSF-UK (2014-06)
      PRIMARY OBJECTIVES of study: To compare the in vivo efficacy of artesunate-amodiaquine (ASAQ) versus artemether-lumefantrine (Coartem®) in a population of children aged between 6 and 59 months suffering from uncomplicated P. falciparum malaria. This will be expressed as the PCR genotyping corrected rates of parasite clearance as a measure of efficacy at day 42 after initiation of anti-malarial therapy (the correction is for recrudescence versus re-infection). This will provide the MoH with evidence for the most appropriate choice of ACT for this region. SECONDARY OBJECTIVES: - To measure the PCR uncorrected efficacy of both drugs at day 42 after treatment initiation - To measure the PCR corrected and uncorrected efficacy of both drugs at days 14 and 28 after treatment initiation - To calculate the proportion of early therapeutic failures, late clinical failures and late parasitological failures in a period of 42 days after treatment initiation - To formulate recommendations and to enable the Ministry of Health to make informed decisions about
    • Research Protocol - Elevation and cholera: an epidemiological spatial analysis of the cholera epidemic in Harare, Zimbabwe, 2008-2009

      Fernandez, M; Schomaker, Michael; Mason, Peter R; Fesselet, Jean François; Baudot, Yves; Boulle, Andrew; Maes, Peter; Centre of Infectious Disease Epidemiology and Research (CIDER), University of Cape Town; Biomedical Research & Training Institute and the University of Zimbabwe College of Health Sciences; MSF Amsterdam; NADAR sprl, Geographic Information Systems; MSF Brussels (2012-06-18)
      Background In highly populated African urban areas where access to clean water is a challenge, water source contamination is one of the most cited risk factors in a cholera epidemic. During the rainy season, where there is either no sewage disposal or working sewer system, runoff of rains follows the slopes and gets into the lower parts of towns where shallow wells could easily become contaminated by excretes. In cholera endemic areas, spatial information about topographical elevation could help to guide preventive interventions. This study aims to analyze the association between topographic elevation and the distribution of cholera cases in Harare during the cholera epidemic in 2008 and 2009. Methods We developed an ecological study using secondary data. First, we described attack rates by suburb and then calculated rate ratios using whole Harare as reference. We illustrated the average elevation and cholera cases by suburbs using geographical information. Finally, we estimated a generalized linear mixed model (under the assumption of a Poisson distribution) with an Empirical Bayesian approach to model the relation between the risk of cholera and the elevation in meters in Harare. We used a random intercept to allow for spatial correlation of neighboring suburbs. Results This study identifies a spatial pattern of the distribution of cholera cases in the Harare epidemic, characterized by a lower cholera risk in the highest elevation suburbs of Harare. The generalized linear mixed model showed that for each 100 meters of increase in the topographical elevation, the cholera risk was 30% lower with a rate ratio of 0.70 (95% confidence interval=0.66-0.76). Sensitivity analysis confirmed the risk reduction with an overall estimate of the rate ratio between 20% and 40%. Conclusion This study highlights the importance of considering topographical elevation as a geographical and environmental risk factor in order to plan cholera preventive activities linked with water and sanitation in endemic areas. Furthermore, elevation information, among other risk factors, could help to spatially orientate cholera control interventions during an epidemic.
    • Research Protocol - Evaluating the effectiveness and burden of diabetes care in a complex humanitarian emergency setting in Mweso, North Kivu, Democratic Republic of the Congo (DRC), 2015

      Caleo, Grazia; Ngadjo, Cyril; Roberts, Bayard; Kitembo, Augustin Wika; Jobanputra, Kiran; Perel, Pablo; de la Croix, Jean; Preito, DAvid; SAdique, Zia; de Wit, Marit; MSF UK, London; Ministry of Health, Mweso, DRC; LSHTM, London; MSF OCA, DRC; LSHTM, London; MSF OCA, DRC; MSF OCA, DRC; LSHTM, London; LSHTM, London; MSF OCA, Amsterdam (2015-08-03)
      Overall aim: To evaluate IDC-OPD in Mweso health zone, North Kivu, DRC. The specific objectives are to examine: • The reach (coverage) of the diabetes service to the intended target population. • The effectiveness of IDC-OPD in improving diabetes outcomes (fasting blood glucose and complications) • Adoption / acceptance of IDC-OPD by staff and patients • Implementation of IDC-OPD in terms of consistency/fidelity, adaptation and costs • Maintenance of IDC-OPD in patients and programme over time
    • Research Protocol - Evaluation of the Nova StatSensor Xpress Creatinine Point-Of-Care Handheld Analyzer

      Kosack, Cara Simone; de Kieviet, Wim; Bayrak, Kubra; Milovic, Anastacija; Page, Anne Laure; MSF Amsterdam; Department of Clinical Chemistry, Sint Lucas Andreas Ziekenhuis, Amsterdam, Netherlands; Epicentre, Paris, France (2015-04-17)
      To evaluate the precision and accuracy of the Nova StatSensor® XpressTM Creatinine when compared to the reference method (Ortho Vitros)) at Sint Lucas Andreas Ziekenhuis (SLAZ), Amsterdam, the Netherlands.
    • Research Protocol - Factors Related to Fetal Death in Pregnant Women with Cholera, Haiti, 2011–2014

      Schillberg, E; Ariti, Cono; Bryson, L; Delva-Senat, R; Price, D; GrandPierre, R; Lenglet, A; MSF Haiti; London School of Hygiene and Tropical Medicine, London, UK; MSF Amsterdam; Ministère de la Santé Publique et de la Population, Port-au-Prince (2017-01-13)
      We assessed risk factors for fetal death during cholera infection and effect of treatment changes on these deaths. Third trimester gestation, younger maternal age, severe dehydration, and vomiting were risk factors. Changes in treatment had limited effects on fetal death, highlighting the need for prevention and evidence-based treatment.
    • Research Protocol - Inpatient signs and symptoms and factors associated with death among children aged ≤5 years admitted to two Ebola Management Centres in Sierra Leone, 2014: a retrospective cohort study

      Shah, Tejshri; Caleo, Grazia; Lokuge, Kamalini (2015-12-16)
      1. To describe the source case for children 2. To describe the viral load at presentation 3. To document the intervals between symptom onset and presentation for those who die and those who survive 4. To describe early symptoms of Ebola virus disease 5. To assess the association between risk factors and death
    • Research Protocol - Inpatient signs and symptoms and factors associated with death in children aged 5 years and younger admitted to two Ebola management centres in Sierra Leone, 2014: a retrospective cohort study

      Shah, Tejshri; Greig, Jane; van der Plas, LM; Achar, J; Caleo, Grazia; Squire, James Sylvester; Turay, AS; Joshy, G; D’Este, C; Banks, E; et al. (2016-07)
      Background Médecins Sans Frontières (MSF) opened Ebola management centres (EMCs) in Sierra Leone in Kailahun in June, 2014, and Bo in September, 2014. Case fatality in the west African Ebola virus disease epidemic has been highest in children younger than 5 years. Clinical data on outcomes can provide important evidence to guide future management. However, such data on children are scarce and disaggregated clinical data across all ages in this epidemic have focussed on symptoms reported on arrival at treatment facilities, rather than symptoms and signs observed during admission. We aimed to describe the clinical characteristics of children aged 5 years and younger admitted to the MSF EMCs in Bo and Kailahun, and any associations between these characteristics and mortality. Methods In a retrospective cohort study, we included data from children aged 5 years and younger with laboratory-confirmed Ebola virus disease admitted to EMCs between June and December, 2014. We described epidemiological, demographic, and clinical characteristics and viral load (measured using Ebola virus cycle thresholds [Ct]), and assessed their association with death using Cox regression modelling. Findings We included 91 children in analysis; 52 died (57·1%). Case fatality was higher in children aged less than 2 years (76·5% [26/34]) than those aged 2–5 years (45·6% [26/57]; adjusted HR 3·5 [95% CI 1·5–8·5]) and in those with high (Ct<25) versus low (Ct≥25) viral load (81·8% [18/22] vs 45·9% [28/61], respectively; adjusted HR 9·2 [95% CI 3·8–22·5]). Symptoms observed during admission included: weakness 74·7% (68); fever 70·8% (63/89); distress 63·7% (58); loss of appetite 60·4% (55); diarrhoea 59·3% (54); and cough 52·7% (48). At admission, 25% (19/76) of children were afebrile. Signs significantly associated with death were fever, vomiting, and diarrhoea. Hiccups, bleeding, and confusion were observed only in children who died. Interpretation This description of the clinical features of Ebola virus disease over the duration of illness in children aged 5 years and younger shows symptoms associated with death and a high prevalence of distress, with implications for clinical management. Collection and analysis of age-specific data on Ebola is very important to ensure that the specific vulnerabilities of children are addressed.
    • Research Protocol - Mortality Rates above Emergency Threshold in Population Affected by Conflict in North Kivu, Democratic Republic of Congo, July 2012–April 2013

      Carrión Martín, A I; Bil, K; Salumu, P; Baabo, D; Singh, J; Kik, C; Lenglet, A; MSF Amsterdam; Médecin Inspecteur Provinciale, Goma, North Kivu, Democratic Republic of Congo; Zone de Santé, Walikale, North Kivu, Democratic Republic of Congo (2014-09-18)
      The area of Walikale in North Kivu, Democratic Republic of Congo, is intensely affected by conflict and population displacement. Médecins-Sans-Frontières (MSF) returned to provide primary healthcare in July 2012. To better understand the impact of the ongoing conflict and displacement on the population, a retrospective mortality survey was conducted in April 2013. A two-stage randomized cluster survey using 31 clusters of 21 households was conducted. Heads of households provided information on their household make-up, ownership of non-food items (NFIs), access to healthcare and information on deaths and occurrence of self-reported disease in the household during the recall period. The recall period was of 325 days (July 2012–April 2013). In total, 173 deaths were reported during the recall period. The crude mortality rate (CMR) was of 1.4/10,000 persons/day (CI95%: 1.2–1.7) and the under-five- mortality rate (U5MR) of 1.9/10,000 persons per day (CI95%: 1.3–2.5). The most frequently reported cause of death was fever/malaria 34.1% (CI95%: 25.4–42.9). Thirteen deaths were due to intentional violence. Over 70% of all households had been displaced at some time during the recall period. Out of households with someone sick in the last two weeks, 63.8% sought health care; the main reason not to seek health care was the lack of money (n = 134, 63.8%, CI95%: 52.2–75.4). Non Food Items (NFI) ownership was low: 69.0% (CI95%: 53.1–79.7) at least one 10 liter jerry can, 30.1% (CI95%: 24.3–36.5) of households with visible soap available and 1.6 bednets per household. The results from this survey in Walikale clearly illustrate the impact that ongoing conflict and displacement are having on the population in this part of DRC. The gravity of their health status was highlighted by a CMR that was well above the emergency threshold of 1 person/10,000/day and an U5MR that approaches the 2 children/10,000/day threshold for the recall period.
    • Research Protocol - Post-kala-azar Dermal Leishmaniasis (PKDL): a prospective observational study of the effectiveness and safety of an ambulatory short course treatment with AmBisome* 15 mg/kg total dose

      Ritmeijer, Koert; Kumar Das, Asish; Ahmed, Be-Nazir; den Boer, Margriet; Almeida, Patrick; Verputten, Meggy; MSF-Holland, Amsterdam, The Netherlands; MSF-Holland, Fulbaria, Bangladesh; CDC, (DGHS); MSF-Holland, Amsterdam, The Netherlands; MSF-Holland, Dhaka, Bangladesh; MSF-Holland, Amsterdam, The Netherlands (2014-06)
      General objective To evaluate the effectiveness and safety of PKDL treatment with AmBisome 15 mg/kg total dose, given over 15 days in 5 infusions (twice weekly) of 3mg/kg on an ambulatory basis in a primary health care setting. Primary objective: to evaluate the effectiveness of AmBisome 15 mg/kg total dose at 12 M Secondary objective: • Evaluate the safety of AmBisome 3mg/kg x 5 infusions (twice weekly) (15 mg/kg total dose) • Evaluate the occurrence of hypokalaemia • Evaluate at which point in time lesions start to respond to treatment.