Trial of Artesunate Combination Therapy in Pakistan
|ClinicalTrials.gov Identifier: NCT00959517|
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : August 14, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Uncomplicated Falciparum Malaria||Drug: artesunate (AS) Drug: sulphadoxine-pyrimethamine (SP) Drug: Chloroquine (CQ) Drug: primaquine (PQ)||Phase 2|
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.
- CQ+ artesunate
Patients were allocated to treatment groups using a pseudo-randomised table split by age and sex.
- Clinical and parasitological cure/treatment failure by day 28.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||588 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||August 2006|
|Experimental: CQ||Drug: Chloroquine (CQ)|
|Experimental: CQ+PQ||Drug: Chloroquine (CQ) Drug: primaquine (PQ)|
|Experimental: CQ + AS||
Drug: artesunate (AS)
Recommended dosage over 3 days (for all interventions)Drug: Chloroquine (CQ)
|Experimental: SP||Drug: sulphadoxine-pyrimethamine (SP)|
|Experimental: SP + PQ||Drug: sulphadoxine-pyrimethamine (SP) Drug: primaquine (PQ)|
|Experimental: SP + AS||
Drug: artesunate (AS)
Recommended dosage over 3 days (for all interventions)Drug: sulphadoxine-pyrimethamine (SP)
- Parasitological outcome after 28 days follow-up [ Time Frame: 28 days ]
- Asexual parasite clearance by day 7 [ Time Frame: 7 days ]
- Gametocyte carriage on or after day 7 [ Time Frame: 7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959517
|Principal Investigator:||Mark W Rowland, PhD||London School of Hygiene and Tropical Medicine|