Trial of Artesunate Combination Therapy in Pakistan
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|