Multicentre field trial of ofloxacin-containing Multidrug Therapy (MDT) in leprosy (Philippines)

ISRCTN ISRCTN73698240
DOI https://doi.org/10.1186/ISRCTN73698240
Secondary identifying numbers 920335
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

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Email pannikerv@who.int

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLeprosy
InterventionTherapeutic 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ofloxacin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date08/04/2003
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaAll patients suspected of leprosy without previous treatments with MDT or ofloxacin in dermatological consultation and referred to the Leprosy Unit.
Key exclusion criteria1. Patients with provincial addresses, temporary addresses and temporary works
2. Patients not residing in targeted areas for the study
Date of first enrolment08/04/2003
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Philippines
  • Switzerland

Study participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Website http://www.who.int
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan