Assessing three day pentamidine for early stage human African trypanosomiasis (Angola)
| ISRCTN | ISRCTN35617647 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35617647 |
| Protocol serial number | A30765 |
| Sponsor | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funder | United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR) |
- Submission date
- 15/04/2005
- Registration date
- 07/06/2005
- Last edited
- 06/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Melba Gomes
Scientific
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| gomesm@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Pharmacokinetic studies have shown that pentamidine has a large volume of distribution and elimination occurs over a long period. The objective of the study is to assess the efficacy of 3 days Intramuscular (IM) pentamidine treatment compared to the standard 7 days IM pentamidine treatment regimen. |
| Ethics approval(s) | Ethics approval received from: 1. World Health Organization (WHO)/Ethics Review Committee (ERC) on the 4th December 2003 2. Instituto de Combate e Control o Das Triponosommiases (ICCT) (Angola) on the 18th October 2004 3. Wandsworth Local Research Ethics Committee (UK) on the 3rd December 2003 |
| Health condition(s) or problem(s) studied | Human African Trypanosomiasis (HAT) |
| Intervention | This will be an open, randomised comparison of two pentamidine treatment regimens, given over three days or seven days with a non-inferiority trial design. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pentamidine |
| Primary outcome measure(s) |
Proportion of cases with favourable progress at 6 months, based on clinical state and laboratory status. |
| Key secondary outcome measure(s) |
1. Proportion of cases with favourable progress at discharge, 3 and 12 months based on clinical state and laboratory status |
| Completion date | 20/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 440 |
| Key inclusion criteria | 1. Aged more than or equal to 14 years and less than 60 years 2. Parasite positive (on examination of lymph juice, by Capillary Tube Centrifugation [CTC] or miniature Anion-Exchange Centrifugation [mAEC] on whole blood) 3. Alternative diagnoses excluded clinically and by appropriate laboratory investigations 4. Capable of and giving informed consent to the study |
| Key exclusion criteria | 1. Stage II Human African Trypanosomiasis (HAT): defined as parasites in cerebrospinal fluid (CSF), or having more than or equal to 6 cells/mm^3 in CSF; or more than 100 red cells/mm^3 ("bloody tap") 2. Pregnant 3. Previous HAT 4. Known allergy or reactions to pentamidine 5. Diabetes mellitus 6. Difficulty to comply with follow-up (patients of no fixed abode and refugees, for example) |
| Date of first enrolment | 20/12/2004 |
| Date of final enrolment | 20/12/2006 |
Locations
Countries of recruitment
- Angola
- Switzerland
Study participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
