Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

Malaria Clinical Trial

Official title:

Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00453856
• Other study ID #: IPTi-DRWG- SP Lambaréné
• Status: Terminated
• Phase: Phase 4
• First received: March 28, 2007
• Last updated: August 8, 2007
• Start date: March 2007

Study information

• Verified date: August 2007
• Source: Albert Schweitzer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gabon: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.

In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium, and to provide information for policy makers regarding the predicted efficacy of IPTi, it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted. The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the "in vivo efficacy study," which follows a standardized World Health Organization protocol.

A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage and/or spread of drug resistant P. falciparum parasites.

Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear.

Description:

Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged 6-59 month old children in Lambaréné at enrolment, if eligible according to the approved protocol.

139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated malaria. Thereafter each subject will be followed according to the approved protocol

The proportion of subjects with Adequate Clinical and Parasitological response (ACPR) by day 28, Early Treatment Failure (ETF), Late Clinical Failure (LCF) and Late Parasitological Failure (LPF)will be evaluated.

secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 139
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Male and female outpatients

• Aged 6 to 59 months

• Body weight between 7.5 to 30 kg

• uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL

• Ability to tolerate oral therapy

• Informed consent, oral agreement of the child if appropriate

Exclusion Criteria:

• Still in IPTi trial and/or still in any other intervention trial

• Known G6PD-deficiency

• Presence of severe malnutrition

• Inability to drink or breastfeed

• Recent history of convulsions, lethargy or unconsciousness;

• Signs of severe and complicated

• Mixed/mono infection that includes a non-P. falciparum species.

• Hb < 7g/dl

• Inability to attend stipulated follow-up visits.

• History of hypersensitivity reactions to the drug being evaluated

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Sulfadoxine Pyrimethamine

Locations

Country	Name	City	State
Gabon	Medical Research Unit of the Albert Schweitzer Hospital	Lambaréné	Moyen Ogooué

Sponsors (2)

Lead Sponsor	Collaborator
Albert Schweitzer Hospital	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria,
Secondary	Determine the frequency of molecular markers for drug resistance

External Links

•   (Homepage of the Medical Research Unit, Lambaréné)