Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Deutscher Akademischer Austausch Dienst
Volkswagen-Stiftung (VW-Stiftung)
Information provided by:
Bernhard Nocht Institute for Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00206739
First received: September 13, 2005
Last updated: March 29, 2010
Last verified: September 2005
  Purpose

The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality


Condition Intervention Phase
Malaria
Anemia
Drug: Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infant: a Randomized, Double-blind, and Placebo-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Bernhard Nocht Institute for Tropical Medicine:

Primary Outcome Measures:
  • • Efficacy of an extended intermittent treatment with sulfadoxine-pyrimethamine for the control of clinical malaria and anemia (proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 21 months of life)
  • • Determination of the rate of clinical malaria and anemia after suspending an extended intermittent treatment for analysis of possible rebound effects
  • • Evaluation of safety and adverse effects of the administration of single doses of sulfadoxine-pyrimethamine in infants and children

Secondary Outcome Measures:
  • • Rate and time points of hospitalizations with anemia, malaria or other diseases
  • • Rate and time points of severe anemia episodes
  • • Proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 12 months of life
  • • Antibody responses against parasite antigens
  • • Multiplicity of P. falciparum infections
  • • Proportion of P. falciparum isolates with SP resistance
  • • Influence of host genetic variants on the rate of P. falciparum infections

Enrollment: 1070
Study Start Date: January 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Detailed Description:

In order to define the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine, a novel principle of malaria intervention, the following parameters are evaluated: i) the level of protection from malaria attacks and episodes of anemia during the treatment period, ii) the level of protection from severe malaria during the treatment period, iii) the effect on malaria morbidity after sustaining treatment, iv) the decrease of overall morbidity and mortality, including the number of hospital admissions and visits of hospital outpatient departments v) the influence of the intervention on the development of drug resistances, vi) the impact of the intervention on the development of immunity, vii) the possible influence of the intervention on sub-clinical organ dysfunction due to chronic Plasmodium falciparum infection. Parts of the study are performed in collaboration with the Laboratory of Research, Hospital Albert Schweitzer, Lambaréné, Gabon and the School of Medicine and Health Sciences, University of Development Studies, Tamale, Ghana

  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 parent/guardian (written or oral)
  • Permanent residentship in the study area
  • Age of 3 months +/-4 weeks

Exclusion Criteria:

  • Hypersensitivity to sulfonamides or pyrimethamine (skin rashes, evidence of hemolysis including dark urine and/or purpura, presumptive signs of bone marrow depression such as sore throat and/or mouth ulcers)
  • Other severe adverse events related to pyrimethamine-sulfadoxine application
  • Signs of severe hepatic or renal dysfunction not due to malaria
  • Other reasons after decision of the study physician
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206739

Locations
Ghana
Kumasi Centre for Collaborative Research in Tropical Medicine
Kumasi, Ashanti Region, Ghana
Sponsors and Collaborators
Bernhard Nocht Institute for Tropical Medicine
German Federal Ministry of Education and Research
Deutscher Akademischer Austausch Dienst
Volkswagen-Stiftung (VW-Stiftung)
Investigators
Principal Investigator: Ohene Adjei, Prof. Dr. Kumasi Centre for Collaborative Research in Tropical Medicine
Study Director: Jürgen May, PD Dr. Bernhard Nocht Institute for Tropical Medicine Hamburg, Infection Epidemiology
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00206739     History of Changes
Other Study ID Numbers: 01KA0202-K7.3, 01KA0202
Study First Received: September 13, 2005
Last Updated: March 29, 2010
Health Authority: Ghana: Ministry of Health

Keywords provided by Bernhard Nocht Institute for Tropical Medicine:
Malaria
Anemia
IPTi
Intermittent Preventive Treatment in Infants
Sulfadoxine-Pyrimethamine
Chemoprophylaxis
Ghana

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

ClinicalTrials.gov processed this record on September 18, 2014