Multicentre field trial of ofloxacin-containing Multidrug Therapy (MDT) in leprosy (Philippines)
| ISRCTN | ISRCTN73698240 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73698240 |
| Protocol serial number | 920335 |
| 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
- 05/04/2005
- Registration date
- 07/06/2005
- Last edited
- 26/03/2008
- 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 V.E. Pannikar
Scientific
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| pannikerv@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Leprosy |
| Intervention | Therapeutic efficacy of new MDT regimen containing Ofloxacin, in comparison with the standard World Health Organization (WHO)/MDT regimen among paucibacillary (PB) and multibacillary (MB) leprosy patients. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ofloxacin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | All patients suspected of leprosy without previous treatments with MDT or ofloxacin in dermatological consultation and referred to the Leprosy Unit. |
| Key exclusion criteria | 1. Patients with provincial addresses, temporary addresses and temporary works 2. Patients not residing in targeted areas for the study |
| Date of first enrolment | 08/04/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Philippines
- 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 |
