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Intermittent Antimalaria Treatment With SP in African Children
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Charite University, Berlin, Germany
DAAD (Deutscher Akademischer Austauschdienst)
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00168948
  Purpose

- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana


Condition Intervention Phase
Malaria
Anemia
 Drug: Sulfadoxin (12.5) Pyrimethamine (250 mg)
 Phase IV

MedlinePlus related topics: Anemia Malaria
Drug Information available for: Pyrimethamine Sulfadoxine Fansidar
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Efficacy and safety of IPTi with SP
  • Impact of IPTi on incidence on malaria attacks
  • Impact of IPTi on anemia

Secondary Outcome Measures:
  • Interaction between erythrocyte polymorphisms and SP
  • Influence on parasite multiplicity
  • Impact on child development

Estimated Enrollment: 1200
Study Start Date: March 2003
Estimated Study Completion Date: August 2005
Detailed Description:
  • Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
  • It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
  • It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
  • Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined
  Eligibility

Ages Eligible for Study:   2 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • informed consent by parents or guardian
  • no concomitant serious disease
  • age >2 months

Exclusion Criteria:

  • serious allergy or hypersensitivity to sulfonamides or pyrimethamine
  • no severe hepatic or renal dysfunction
  • serious breach of study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168948

Sponsors and Collaborators
Charite University, Berlin, Germany
DAAD (Deutscher Akademischer Austauschdienst)
Investigators
Study Director: Frank Mockenhaupt, PhD Charite University-Medicine, Berlin, Germany
  More Information

Click here for more information about this study  This link exits the ClinicalTrials.gov site

Publications:
Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7.
Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50.
Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60.

Study ID Numbers: 01KA0202-T, 01KA0202
Study First Received: September 13, 2005
Last Updated: November 1, 2005
ClinicalTrials.gov Identifier: NCT00168948  
Health Authority: Ghana: Ministry of Health

Keywords provided by Charite University, Berlin, Germany:
Intermittent preventive treatment
IPTi
Malaria control
Ghana

Study placed in the following topic categories:
Folic Acid
Pyrimethamine
Protozoan Infections
Sulfadoxine-pyrimethamine
 Anemia
Parasitic Diseases
Malaria
Sulfadoxine

Additional relevant MeSH terms:
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
 Coccidiosis
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009



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