Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria
To determine whether two cheap antifolates (chlorproguanil-dapsone and sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are sufficiently effective against vivax malaria to be deployed in areas where diagnosis is poor and the burden of malaria is high, a randomised controlled trial of the three drugs is being undertaken comparing their efficacy in treating malaria.
Drug: sulfadoxine-pyrimethamine and chlorproguanil-dapsone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||An Open-Label Three Arm Trial of the Efficacy and Safety of Chlorproguanil / Dapsone (Lapdap) Compared With Chloroquine and Sulfadoxine / Pyrimethamine for the Treatment of Vivax Malaria in Pakistan and Afghanistan|
- Day 14 slide clearance rate (complete clearance of parasites), assessed by microscopists who are blind to treatment allocation.
- Day 28 slide clearance rate defined as the number of treated patients with clearance of parasitaemia within 14 days of starting treatment, without subsequent recrudescence up to day 28.
- Day 14 clinical failure rate (presence of symptoms of malaria in the presence of parasitaemia).
- Day 28 clinical failure rate.
- Adverse events.
- Haemoglobin level increased by at least 1g/dl by day 14.
- Clearance of gametocytaemia by day 3, 7, and 14.
- Number of subsequent malaria episodes in next 6 months. It is assumed that the population of each treatment arm is equally likely to be re-infected in this time scale. Therefore any measurable difference in number of subsequent episodes between treatment
- In G6PD deficient patients the change in mean haemoglobin.
|Study Start Date:||February 2004|
|Study Completion Date:||March 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158561
|Principal Investigator:||Christopher Whitty, FRCP||LSHTM|
|Study Director:||Mark Rowland, PhD||LSHTM|