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Trial of Artesunate Combination Therapy in Pakistan

2014-08-27 03:20:02 | BioPortfolio

Summary

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.

Description

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Conditions

Uncomplicated Falciparum Malaria

Intervention

artesunate (AS), sulphadoxine-pyrimethamine (SP), Chloroquine (CQ), primaquine (PQ)

Location

HealthNet International
Peshawar
Pakistan

Status

Completed

Source

London School of Hygiene and Tropical Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:02-0400

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Medical and Biotech [MESH] Definitions

A synthetic TETRACYCLINE derivative with similar antimicrobial activity. Animal studies suggest that it may cause less tooth staining than other tetracyclines. It is used in some areas for the treatment of chloroquine-resistant falciparum malaria (MALARIA, FALCIPARUM).

A species of protozoa that is the causal agent of falciparum malaria (MALARIA, FALCIPARUM). It is most prevalent in the tropics and subtropics.

An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404)

Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.

Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.

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