Clinical study on alternative treatment of patients with second stage Trypanosoma brucei gambiense sleeping sickness
| ISRCTN | ISRCTN36877262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36877262 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/11/2005
- Registration date
- 16/12/2005
- Last edited
- 31/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Philippe Büscher
Scientific
Scientific
Institute of Tropical Medicine
Department of Parasitology
Nationalestraat 155
Antwerpen
2000
Belgium
| Phone | +32 (0)3 247 63 71 |
|---|---|
| pbuscher@itg.be |
Study information
| Study design | An open randomised trial was designed to test equivalence between standard melarsoprol and 3 other regimens. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The difference in efficacy between classical melarsoprol treatment and alternative treatment regimens is lower than 15% |
| Ethics approval(s) | Yes. The study protocol was approved by the Ministry of Health, Kinshasa, Democratic Republic of the Congo (DRC) in December 1997. |
| Health condition(s) or problem(s) studied | Trypanosoma brucei gambiense Human African Trypanosomiasis in second stage |
| Intervention | A. Standard melarsoprol as administered in the DRC: 3 series of 3.6 mg/kg/day intravenously (IV) (maximum 180 mg/day) for 3 days with 7-day breaks in between series. Total dose: 32.4 mg/kg. B. Concise, consecutive lower-dose melarsoprol: IV during 10 days (0.6 mg/kg on day 1; 1.2 mg/kg on day 2; 1.8 mg/kg from days 3 to 10; maximum 90 mg/day). Total dose: 16.2 mg/kg. C. Nifurtimox monotherapy: orally, under nurse supervision, 5 mg/kg every 8 hours for 14 days. Total dose: 210 mg/kg. D. Low-dose concise, consecutive melarsoprol-nifurtimox combination: 2 days melarsoprol alone (0.6 mg/kg on day 1; 1.2 mg/kg on day 2) followed by 8 days 7.5 mg/kg nifurtimox every 12 hours combined with melarsoprol 1.2 mg/kg/day. Total melarsoprol dose: 11.4 mg/kg. Total nifurtimox dose: 120 mg/kg. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Melarsoprol, Nifurtimox |
| Primary outcome measure | Primary outcomes were relapse, severe adverse events and death attributed to treatment. |
| Secondary outcome measures | Secondary outcomes were frequency of other adverse events |
| Overall study start date | 01/02/1998 |
| Completion date | 31/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1, Older than 15 years 2. Second-stage parasitologically confirmed T. b. gambiense infection 3. Never previously treated for sleeping sickness Second stage disease was defined as: 1° cerebrospinal fluid (CSF) white blood cell (WBC) count >20 /µl and detectable IgM in the CSF; or 2° trypanosomes detected in CSF. |
| Key exclusion criteria | 1. Glasgow coma scale <8 2. Pregnancy 3. Active tuberculosis 4. Positive syphilis serology 5. Bacterial or cryptococcal meningitis 6. Severe anaemia 7. Severe renal or hepatic dysfunction 8. Hemorrhagic CSF 9. Residence beyond 100 km from Bwamanda Hospital |
| Date of first enrolment | 01/02/1998 |
| Date of final enrolment | 31/05/2001 |
Locations
Countries of recruitment
- Belgium
- Congo, Democratic Republic
Study participating centre
Institute of Tropical Medicine
Antwerpen
2000
Belgium
2000
Belgium
Sponsor information
Institute of Tropical Medicine (Belgium)
University/education
University/education
Nationalestraat 155
Antwerpen
2000
Belgium
| Website | http://www.itg.be |
|---|---|
"ROR" |
https://ror.org/03xq4x896 |
Funders
Funder type
Research organisation
Institute of Tropical Medicine (Belgium)
No information available
Belgian Directorate-General for Development Co-operation (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/02/2007 | No | No |
