Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants
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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 |
- • 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
- • 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) |
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 |
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| Ghana | |
| Kumasi Centre for Collaborative Research in Tropical Medicine | |
| Kumasi, Ashanti Region, Ghana | |
| 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:
|
Anemia Malaria Hematologic Diseases Protozoan Infections Parasitic Diseases Pyrimethamine Sulfadoxine Sulfadoxine-pyrimethamine Antimalarials Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on May 16, 2013