Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

Sponsor

Albert Schweitzer Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00453856

Collaborator

Bill and Melinda Gates Foundation (Other)

139

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Sulfadoxine Pyrimethamine	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

139 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria, []

Secondary Outcome Measures

Determine the frequency of molecular markers for drug resistance []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Unit of the Albert Schweitzer Hospital	Lambaréné	Moyen Ogooué	Gabon	B.P. 118

Sponsors and Collaborators

Albert Schweitzer Hospital
Bill and Melinda Gates Foundation

Investigators

Study Director: Martin P Grobusch, MD, Medical Research Unit, Albert Schweitzer Hospital Lambaréné
Principal Investigator: Saadou Issifou, MD MSc, Albert Schweitzer Hospital