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SPK Study in Afghanistan

NCT01707199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2020-10-14

No results posted yet for this study

Summary

In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium falciparum resistance to chloroquine. In 2003 the high failure rate of chloroquine against falciparum malaria led the national malaria treatment programme to switch its recommended first line drug treatment for uncomplicated Plasmodium falciparum malaria to artemisinin-based combination therapy (ACT) in the form of Artesunate/Sulphadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7 days).

For operational reasons, prior to recent studies (manuscript in preparation) there have been no molecular data on P. falciparum SP resistance markers from within the borders of Afghanistan. These studies have revealed early evidence of increasing SP resistance (resistance polymorphisms with double DHFR \& triple DHPS mutations). The aim of this study is to conduct a focused, prospective study in Kunar for monitoring of the efficacy of the AS+SP combination in this province, along with molecular studies of isolates from recruited patients.

Conditions

  • Uncomplicated P. Falciparum Malaria

Interventions

DRUG

Artesunate + Sulphadoxine-pyrimethamine

AS+SP will be administered according to the patient's age, based on a dose of 4mg artesunate/kg body weight once daily for 3 days plus SP at a dose of 25mg sulphadoxine/kg body weight single dose on the first day. One co-blister pack of Artecospe will be used per patient and obtained via WHO from Guilin Pharmaceutical Co. Ltd., Shanghai China, with appropriate expiry date.

Sponsors & Collaborators

Principal Investigators

  • Ghulam Rahim Awab, MD · Research Dept. Ministry of Public Health (MoPH) Afghanistan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Afghanistan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01707199 on ClinicalTrials.gov