Uncomplicated Falciparum Malaria Clinical Trial
Official title:
Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
This study is an evaluation of the benefit of adding artesunate to existing first and second
line antimalarial therapies in Pakistan.
A placebo controlled trial was carried out to assess two potential benefits of Artesunate
Combination Therapy (ACT): efficacy and potential for transmission reduction.
A randomised, double-blind placebo controlled study of the efficacy of chloroquine or
sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the
treatment of uncomplicated falciparum malaria.
Arms:
1. CQ
2. CQ+primaquine
3. CQ+ artesunate
4. SP
5. SP+primaquine
6. SP+artesunate
Patients were allocated to treatment groups using a pseudo-randomised table split by age and
sex.
Primary outcomes:
- Clinical and parasitological cure/treatment failure by day 28.
Secondary outcomes:
- time to resolution of fever
- time to clearance of trophozoites
- time to clearance of gametocytes
- gametocyte carriage on or after day 7 after treatment
All clinical assessments and slide readings were carried out by staff blind to treatment
arm. Slides were double read.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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