Clinical trial NCT00489658: Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
Official title: Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Trypanosomiasis, African
Keywords: Human African trypanosomiasis
sleeping sickness
Trypanosoma brucei gambiense
combination
eflornithine
nifurtimox
Human African trypanosomiasis (sleeping sickness) due to Trypanosoma brucei gambiense in the late stage (stage 2 or meningo-encephalitic)
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Médecins Sans Frontières, France
First posted: 2007-06-21
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: Inclusion Criteria:

* Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF \> 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count
* Residence in the study area
* Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)

Exclusion Criteria:

* Pregnancy or clinical history suggestive thereof
* Weight \< 10 Kg
* History of any HAT treatment within the previous 24 months
* Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge
* Severe anemia (Hb\< 5g/dl)
* Active tuberculosis (sputum positive)
* HIV positive (if patient has been tested and results are known)
* Severe renal or hepatic failure
* Bacterial or cryptococcal meningitis
* Other severe underlying diseases upon admission
* Refugee status

Primary outcomes:
measure: 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)
timeFrame: 24 months
Secondary outcomes:
measure: Occurrence and severity of serious clinically apparent adverse events
timeFrame: treatment period and up to one month post discharge
measure: Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events
timeFrame: treatment period
Other outcomes:
Locations:
city: Yumbe
country: Uganda
facility: Yumbe District Hospital
state: Yumbe District
Study officials:
affiliation: Epicentre
name: Patrice Piola, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Epicentre
name: Gerardo Priotto, MD MPH
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1371/journal.pctr.0010039.