Trial of Artesunate Combination Therapy in Pakistan

London School of Hygiene and Tropical Medicine588 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

588

Conditions

Uncomplicated Falciparum Malaria

Interventions

artesunate (AS)DRUG

Recommended dosage over 3 days (for all interventions)

sulphadoxine-pyrimethamine (SP)DRUG

Chloroquine (CQ)DRUG

primaquine (PQ)

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

HealthNet International

Peshawar, Pakistan

Outcomes

Primary Outcomes

Parasitological outcome after 28 days follow-up

Time frame: 28 days

Secondary Outcomes

Asexual parasite clearance by day 7

Time frame: 7 days

Gametocyte carriage on or after day 7

Time frame: 7 days

Data from ClinicalTrials.gov

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