Trial of Artesunate Combination Therapy in Pakistan

Study Overview
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Brief Summary
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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.

Detailed Description
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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: CQ CQ+primaquine CQ+ artesunate SP SP+primaquine 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.

Official Title
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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

Conditions
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Uncomplicated Falciparum Malaria

Intervention / Treatment
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* Drug: artesunate (AS)
* Drug: sulphadoxine-pyrimethamine (SP)
* Drug: Chloroquine (CQ)
* Drug: primaquine (PQ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presentation at basic health unit with suspected clinical malaria mono-infection infection with P. falciparum confirmed by microscopy over 2 years of age (no upper age restriction) weight over 5 kg (no upper weight restriction) if of child bearing age then non-pregnant and willing to remain so for the duration of the study greater than 1 asexual parasite per 10 fields understands and is willing to sign the consent form a resident in the study site willing to collaborate for a full period of follow-up no signs of severe malaria Exclusion Criteria: other serious disease (e.g., cardiac, renal or hepatic) in women of child bearing age, pregnancy allergy to any of the study drugs or related compounds reports to have used any malaria drugs in the last 21 days other species of malaria seen signs of severe malaria

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CQ<br> | Drug: Chloroquine (CQ)<br> <br> |
| Experimental: CQ+PQ<br> | Drug: Chloroquine (CQ)<br> <br> Drug: primaquine (PQ)<br> <br> |
| Experimental: CQ + AS<br> | Drug: artesunate (AS)<br>* Recommended dosage over 3 days (for all interventions)<br>Drug: Chloroquine (CQ)<br> <br> |
| Experimental: SP<br> | Drug: sulphadoxine-pyrimethamine (SP)<br> <br> |
| Experimental: SP + PQ<br> | Drug: sulphadoxine-pyrimethamine (SP)<br> <br> Drug: primaquine (PQ)<br> <br> |
| Experimental: SP + AS<br> | Drug: artesunate (AS)<br>* Recommended dosage over 3 days (for all interventions)<br>Drug: sulphadoxine-pyrimethamine (SP)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasitological outcome after 28 days follow-up |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asexual parasite clearance by day 7 |  | 7 days | 
| Gametocyte carriage on or after day 7 |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placebo controlled, Efficacy, Artemisinin-based combination therapy, Primaquine, Gametocytes