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Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

This study has been terminated.
(The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00453856
First Posted: March 29, 2007
Last Update Posted: August 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
Albert Schweitzer Hospital
  Purpose

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 Intervention Phase
Malaria Drug: Sulfadoxine Pyrimethamine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Albert Schweitzer Hospital:

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

Estimated Enrollment: 139
Study Start Date: March 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453856


Locations
Gabon
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00453856     History of Changes
Other Study ID Numbers: IPTi-DRWG- SP Lambaréné
First Submitted: March 28, 2007
First Posted: March 29, 2007
Last Update Posted: August 10, 2007
Last Verified: August 2007

Keywords provided by Albert Schweitzer Hospital:
Malaria
Sulfadoxine
Pyrimethamine
Resistance
Gabon

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents