Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children

This study has been completed.
Sponsor:
Collaborators:
Department of State for Health and Social Welfare, The Gambia
London School of Hygiene and Tropical Medicine
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00561899
First received: November 20, 2007
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance. The effect of IPT in children in the prevention of malaria has been evaluated in a number of trials in areas of seasonal malaria transmission. Results from these trials have shown that IPTc provided between 40% - 86% protection against clinical malaria. In 2006, a trial that compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia. Preliminary results of the trial have shown that the treatment was very effective as only 4% (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic. Tolerability was assessed in a subset of 1100 children and the results showed that about 13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of the study subjects. Severe adverse events were rare. Thus it is important to investigate if other drug regimens might be equally effective in preventing malaria but less likely to cause adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions during the months of September, October, and November. To determine the prevalence of side effects following drug administration participants in each treatment group will be visited at home three and seven days after each round of drug administration and a side effects questionnaire completed. To help establish whether these adverse events are drug related, the same questionnaire will be administered after each treatment round, to 286 age-matched children who are not part of the trial. The primary ends points will be the incidence of adverse events.


Condition Intervention Phase
Malaria
Drug: SP, amodiaquine, piperaquine, dihdroartemisinin
Drug: intermittent preventive treatment
Drug: Du-Cotecxin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children [ Time Frame: Onset of IPT to end of malaria season ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The efficacy of the three drug regimens when used for seasonal IPT in children [ Time Frame: Onset of IPT to end of malaria season ] [ Designated as safety issue: No ]

Enrollment: 1295
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SP+AQ
Drug: SP, amodiaquine, piperaquine, dihdroartemisinin
once every month during september, October and November
Other Names:
  • Fansidar
  • Du-Cotecxin
Experimental: 2
Piperaquine plus SP arm
Drug: intermittent preventive treatment
SP(500mg sulfadoxine/25mg pyrimethamine)1.25mg SP per kg stat Amodiaquine (200mg base) 25mg/kg over 3 days Piperaquine (320 mg per tablet) 16.8 g/kg daily for 3 days Du-Cotecxin ( 40mg dihydroartemisinin(DHA)/320mg piperaquine(PQP))PQP/DHA 1.6/12.8mg/kg once daily for 3 days
Other Names:
  • SP
  • Du-Cotecxin
Experimental: 3
Du-Cotecxin
Drug: Du-Cotecxin
Du-Cotecxin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days
Other Names:
  • SP
  • Du-Cotecxin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 1 to 5 years at enrolment.
  2. Informed consent obtained from parents or legal guardians.
  3. No current participation in another malaria intervention trial.
  4. Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  5. Available for the duration of the study.

Exclusion Criteria:

  1. Known allergy to any of the antimalarial drugs used in the trial and if this is unknown, then a history of allergic reaction to any drug.
  2. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
  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: NCT00561899

Locations
Gambia
Medical Research Council Laboratories,
Banjul, Gambia
Sponsors and Collaborators
Gates Malaria Partnership
Department of State for Health and Social Welfare, The Gambia
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Kalifa Bojang, MD Medical Research Council Unit, The Gambia
Principal Investigator: Kalifa Bojang, MD Medical Research Council
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kalifa Bojang, MRC Laboratories
ClinicalTrials.gov Identifier: NCT00561899     History of Changes
Other Study ID Numbers: SCC1089, GMP_PII_6
Study First Received: November 20, 2007
Last Updated: March 5, 2009
Health Authority: Gambia: MRC Ethics Committee

Keywords provided by Gates Malaria Partnership:
safety
tolerability
efficacy
intermittent prevetive treatment
children

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014