Nifurtimox-eflornithine Combination Therapy for Second-Stage Trypanosoma Brucei Gambiense Sleeping Sickness: A Randomized Clinical Trial in Congo.

Hdl Handle:
http://hdl.handle.net/10144/20692
Title:
Nifurtimox-eflornithine Combination Therapy for Second-Stage Trypanosoma Brucei Gambiense Sleeping Sickness: A Randomized Clinical Trial in Congo.
Authors:
Priotto, G; Kasparian, S; Ngouama, D; Ghorashian, S; Arnold, U; Ghabri, S; Karunakara, U
Journal:
Clinical Infectious Diseases
Abstract:
BACKGROUND: Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second-stage disease. METHODS: A randomized, open-label, active-control, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by Medecins Sans Frontieres, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. RESULTS: A total of 103 patients with second-stage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the nifurtimox-eflornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the nifurtimox-eflornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the nifurtimox-eflornithine arm. CONCLUSIONS: The nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new nifurtimox-eflornithine combination therapy will mark a major and multifaceted advance over current therapies.
Affiliation:
Epicentre, Paris, France. gpriotto@epicentre.msf.org
Publisher:
Published by: Infectious Diseases Society of America
Issue Date:
1-Dec-2007
URI:
http://hdl.handle.net/10144/20692
DOI:
10.1086/522982
PubMed ID:
17990225
Additional Links:
http://www.journals.uchicago.edu/CID/
Language:
en
ISSN:
1537-6591
Appears in Collections:
Trypanosomiasis/Sleeping Sickness

Full metadata record

DC FieldValue Language
dc.contributor.authorPriotto, G-
dc.contributor.authorKasparian, S-
dc.contributor.authorNgouama, D-
dc.contributor.authorGhorashian, S-
dc.contributor.authorArnold, U-
dc.contributor.authorGhabri, S-
dc.contributor.authorKarunakara, U-
dc.date.accessioned2008-03-14T08:53:23Z-
dc.date.available2008-03-14T08:53:23Z-
dc.date.issued2007-12-01-
dc.identifier.citationNifurtimox-eflornithine Combination Therapy for Second-Stage Trypanosoma Brucei Gambiense Sleeping Sickness: A Randomized Clinical Trial in Congo. 2007, 45 (11):1435-42 Clin. Infect. Dis.en
dc.identifier.issn1537-6591-
dc.identifier.pmid17990225-
dc.identifier.doi10.1086/522982-
dc.identifier.urihttp://hdl.handle.net/10144/20692-
dc.description.abstractBACKGROUND: Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second-stage disease. METHODS: A randomized, open-label, active-control, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by Medecins Sans Frontieres, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. RESULTS: A total of 103 patients with second-stage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the nifurtimox-eflornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the nifurtimox-eflornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the nifurtimox-eflornithine arm. CONCLUSIONS: The nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new nifurtimox-eflornithine combination therapy will mark a major and multifaceted advance over current therapies.en
dc.language.isoenen
dc.publisherPublished by: Infectious Diseases Society of Americaen
dc.relation.urlhttp://www.journals.uchicago.edu/CID/en
dc.rightsArchived on this site with permission and copyright by the Infectious Diseases Society of Americaen
dc.subject.meshAdolescenten
dc.subject.meshAdulten
dc.subject.meshAgeden
dc.subject.meshAnimalsen
dc.subject.meshCongoen
dc.subject.meshDrug Therapy, Combinationen
dc.subject.meshEflornithineen
dc.subject.meshFemaleen
dc.subject.meshHumansen
dc.subject.meshMaleen
dc.subject.meshMiddle Ageden
dc.subject.meshNifurtimoxen
dc.subject.meshTrypanocidal Agentsen
dc.subject.meshTrypanosoma brucei gambienseen
dc.subject.meshTrypanosomiasis, Africanen
dc.titleNifurtimox-eflornithine Combination Therapy for Second-Stage Trypanosoma Brucei Gambiense Sleeping Sickness: A Randomized Clinical Trial in Congo.en
dc.contributor.departmentEpicentre, Paris, France. gpriotto@epicentre.msf.orgen
dc.identifier.journalClinical Infectious Diseasesen

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