Trypanosomiasis, AfricanPhase 3NCT00330148
Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
A Phase 3 study testing melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d, melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d and nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d in people with Trypanosomiasis, African, run by Epicentre at 1 site in Uganda.
Trial summary
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Trypanosomiasis, African
- What is being tested?
- melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d, melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d and nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d
- How many people
- 435 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2001to Jun 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- confirmed second-stage T.b. gambiense infection :
- Infection diagnosed parasitologically (blood or lymph node fluid) and white blood cells > 5/mm3 in cerebrospinal fluid (CSF)
- or Trypanosomes detected in the CSF with any CSF cell count
- and resident in the district
- and written consent of the patient or of one of the parents/guardians for children under 15 years of age.
Who cannot join
- Trypanosome absent from blood (or lymph node fluid) and from CSF
- Or women pregnant on inclusion
- Or previous history of HAT confirmed treated during the last 24 months
- Or impossibility of regular access to the treatment centre during the 2 years following the end of the treatment
- Or less than 10 kg of body weight
- Or refugee patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Comparing the Therapeutic Combinations Melarsoprol-Nifurtimox, Melarsoprol-Eflornithine and Eflornithine-Nifurtimox in the Treatment of Gambiense Human African Trypanosomiasis in the Meningo-Encephalitic Phase
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and expensive to implement in endemic countries. nifurtimox, registered only for Chagas' disease but used off-label since the 1970's in series of cases of HAT, is at present the only other available alternative.
The very limited number of compounds available, the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations.
This study evaluates the efficacy and safety of three drug combination therapies: melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.
Read the detailed description
Dosages per drug are the same in either arm of the study: IV melarsoprol 1.8 mg/kg/day, daily for 10 days; IV eflornithine 400 mg/kg/day, 6-hourly for 7 days; oral nifurtimox 15 or 20 (children <15 years) mg/kg/day, 8-hourly for 10 days.
For efficacy assessment, patients are followed-up for 24 months after treatment, with planned clinical and laboratory controls.
The safety assessment includes clinical and hematological adverse events.
- Conditions
- Trypanosomiasis, African
- Being tested
- melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d, melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d, nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d
- Keywords
- trypanosomiasis, gambiense, combination drug therapy, sleeping sickness, Uganda
- Medical subject headings
- Trypanosomiasis, African, Trypanosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10dDrug
melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7dDrug
nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7dDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Secondary outcomes (2)
Adverse events temporally associated with the treatment
Major adverse events temporally associated with the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startMar 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trypanosomiasis, AfricanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Médecins Sans Frontières, France, Embassy of France in Uganda, National Sleeping Sickness Control Program, Uganda
- Investigators
- Gerardo Priotto, MD, MPH, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330148
- Sponsor's protocol ID
- EPICENTRE-BTT
- Status last verified
- May 2006
- First submitted
- 24 May 2006
- Last updated
- 26 May 2006
- Results posted
- No
Publications
Legros D, Ollivier G, Gastellu-Etchegorry M, Paquet C, Burri C, Jannin J, Buscher P. Treatment of human African trypanosomiasis--present situation and needs for research and development. Lancet Infect Dis. 2002 Jul;2(7):437-40. doi: 10.1016/s1473-3099(02)00321-3.
PubMed 12127356
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing the Therapeutic Combinations Melarsoprol-Nifurtimox, Melarsoprol-Eflornithine and Eflornithine-Nifurtimox in the Treatment of Gambiense Human African Trypanosomiasis in the Meningo-Encephalitic Phase
- ClinicalTrials.gov ID
- NCT00330148
- Acronym / sponsor ID
- EPICENTRE-BTT
- Conditions
- Trypanosomiasis, African
- Keywords
- trypanosomiasis, gambiense, combination drug therapy, sleeping sickness, Uganda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 435 participants
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Médecins Sans Frontières, France, Embassy of France in Uganda, National Sleeping Sickness Control Program, Uganda
- Study start
- Mar 2001
- Study completion
- Jun 2004
- First posted
- 26 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and expensive to implement in endemic countries. nifurtimox, registered only for Chagas' disease but used off-label since the 1970's in series of cases of HAT, is at present the only other available alternative.
The very limited number of compounds available, the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations.
This study evaluates the efficacy and safety of three drug combination therapies: melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.
Detailed description
Dosages per drug are the same in either arm of the study: IV melarsoprol 1.8 mg/kg/day, daily for 10 days; IV eflornithine 400 mg/kg/day, 6-hourly for 7 days; oral nifurtimox 15 or 20 (children <15 years) mg/kg/day, 8-hourly for 10 days.
For efficacy assessment, patients are followed-up for 24 months after treatment, with planned clinical and laboratory controls.
The safety assessment includes clinical and hematological adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- confirmed second-stage T.b. gambiense infection :
- and resident in the district
- and written consent of the patient or of one of the parents/guardians for children under 15 years of age.
Key exclusion criteria (6 listed)
- Trypanosome absent from blood (or lymph node fluid) and from CSF
- Or women pregnant on inclusion
- Or previous history of HAT confirmed treated during the last 24 months
- Or impossibility of regular access to the treatment centre during the 2 years following the end of the treatment
- Or less than 10 kg of body weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d | Drug | – |
| melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d | Drug | – |
| nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d | Drug | – |
Primary outcome
Cure rate
2 secondary outcomes
Adverse events temporally associated with the treatment
Major adverse events temporally associated with the treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2006.
- Background: PubMed 12127356Legros D, Ollivier G, Gastellu-Etchegorry M, Paquet C, Burri C, Jannin J, Buscher P. Treatment of human African trypanosomiasis--present situation and needs for research and development. Lancet Infect Dis. 2002 Jul;2(7):437-40. doi: 10.1016/s1473-3099(02)00321-3.
Related trials for Trypanosomiasis, African
RecruitingPhase 3
Stop Transmission of Gambiense Human African Trypanosomiasis
Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense
Not yet recruitingPhase 3
Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)
Human African Trypanosomiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerardo Priotto, MD, MPH principal investigator
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d, melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d and nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d in people with Trypanosomiasis, African, run by Epicentre at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2006.