Trypanosoma Brucei Rhodesiense; Infection Clinical Trial
Official title:
Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense: a Multicentre, Open-label Clinical Trial
Verified date | October 2022 |
Source | Drugs for Neglected Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims at evaluating the efficacy and safety of a new oral treatment drug against Human African trypanosomiasis (HAT) due to T.b rhodesiense. 34 patients will be recruited in 2 sites located in Malawi and Uganda. All patients will receive the study drug fexinidazole.
Status | Completed |
Enrollment | 45 |
Est. completion date | October 12, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility | Inclusion Criteria: - Signed Informed Consent Form (plus assent for children) - = 6 years old - = 20 kg body weight - Ability to ingest at least one complete meal per day (or at least one Plumpy'NutĀ® sachet) - Karnofsky index = 40 - Parasitological confirmed of T.b. rhodesiense infection - Having a permanent address or being traceable by others and willing and able to comply with follow-up visit schedule - Agreement to be hospitalised for a minimum of 13 days and to receive the study treatment Exclusion Criteria: - Active clinically relevant medical conditions other than HAT that may jeopardize subject safety or at the investigator discretion may interfere with participation in the study. - Compromised general health or severely deteriorated general condition, such as severe malnutrition, cardiovascular shock, respiratory distress, or terminal illness - Known hypersensitivity to fexinidazole, to any nitroimidazole drugs (e.g. metronidazole, tinidazole) or to any of the excipients - Patients previously enrolled in the study or having already received fexinidazole - Patients with severe hepatic impairment (ex: clinical signs of cirrhosis or jaundice) |
Country | Name | City | State |
---|---|---|---|
Malawi | Rumphi District Hospital | Rumphi | |
Uganda | Lwala Hospital | Lwala | Kadeberamaido |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases | European and Developing Countries Clinical Trials Partnership (EDCTP) |
Malawi, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Possibly Related fatality rate at the end of hospitalisation in stage 2 r-HAT patients | Death possibly related to r-HAT or treatment according to DSMB; since at the study sites anatomopathological techniques are not available, the completion of the WHO verbal autopsy questionnaire will be requested in case of death) | 12 to 18 days after start of treatment | |
Secondary | Success rate at the End of Treatment in all stages patients | success is defined as: patient alive and no trypanosomes at end of treatment. Failure is defined as: presence of trypanosomes in any body fluid at end of treatment or death at End of hospitalization. Deaths to be considered are defined as possibly related to r-HAT or treatment according to DSMB. Unrelated deaths are neither success nor failure | 11 days after start of treatment | |
Secondary | Success and failure outcomes at the test of cure | A modification of the WHO recommendations is used to determine success and failure for stage-1 and stage-2 r-HAT patients (Appendix I - Evaluation criteria of efficacy endpoints) | 12 months after start of treatment | |
Secondary | Occurrence of adverse events and serious adverse events | 3. Occurrence of adverse events, including abnormal laboratory or ECG findings, during the observation period (until the end of hospitalisation scheduled up to 7 days after EOT) and those considered as possibly related to r-HAT or treatment, among those detected until the end of the follow-up period (12-month visit). All serious adverse events (SAE) whether they are considered as possibly related to r-HAT treatment or not. | 12 months after start of treatment | |
Secondary | Unsatisfactory clinical and parasitological response | defined as the compound analysis of the clinical evolution (symptoms of HAT) associated with presence of parasites in at least one body fluid (via blood test and/or lumbar puncture) | 11 days after start of treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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