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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 20, 2007 | ||||||||
| Last Updated Date | June 20, 2007 | ||||||||
| Start Date ICMJE | October 2002 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge) [ Time Frame: 24 months ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda | ||||||||
| Official Title ICMJE | Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda | ||||||||
| Brief Summary | This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients. |
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| Detailed Description | |||||||||
| Study Phase | Phase II, Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Open Label, Uncontrolled, Single Group Assignment | ||||||||
| Condition ICMJE | Trypanosomiasis, African | ||||||||
| Intervention ICMJE | Drug: Eflornithine plus Nifurtimox combination therapy | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | Priotto G, Fogg C, Balasegaram M, Erphas O, Louga A, Checchi F, Ghabri S, Piola P. Three Drug Combinations for Late-Stage Trypanosoma brucei gambiense Sleeping Sickness: A Randomized Clinical Trial in Uganda. PLoS Clin Trials. 2006 Dec 8;1(8):e39. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 31 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Uganda | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00489658 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | NECS | ||||||||
| Study Sponsor ICMJE | Epicentre | ||||||||
| Collaborators ICMJE | Medecins Sans Frontieres | ||||||||
| Investigators ICMJE |
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| Information Provided By | Epicentre | ||||||||
| Verification Date | June 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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