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Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Chidren
This study is currently recruiting participants.
Verified by Gates Malaria Partnership, November 2007
Sponsors and Collaborators: Gates Malaria Partnership
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
  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: 1.amodiaquine plus Sulfadoxine-pyrimethamine, 2. piperaquine plus Sulfadoxine-pyrimethamine,3. dihdroartemisinin plus piperaquine
Drug: intermittent preventive treatment
Drug: Artekin
Phase II
Phase III

MedlinePlus related topics: Malaria
Drug Information available for: Pyrimethamine Sulfadoxine Fansidar Dihydroquinghaosu Piperaquine Amodiaquine Amodiaquine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

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 ]

Estimated Enrollment: 1295
Study Start Date: August 2007
Estimated Study Completion Date: June 2008
Arms Assigned Interventions
1: Experimental
SP+AQ
Drug: 1.amodiaquine plus Sulfadoxine-pyrimethamine, 2. piperaquine plus Sulfadoxine-pyrimethamine,3. dihdroartemisinin plus piperaquine
once every month during september, October and November
2: Experimental
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 Artekin ( 40mg dihydroartemisinin(DHA)/320mg piperaquine(PQP))PQP/DHA 1.6/12.8mg/kg once daily for 3 days
3: Experimental
Artekin
Drug: Artekin
Artekin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561899

Contacts
Contact: Kalifa Bojang, MD 220 5668 108 kbojang@mrc.gm
Contact: Brian Greenwood, MD 44 207 299 4707 brian.greenwood@lshtm.ac.uk

Locations
Gambia
Medical Research Council Laboratories, Recruiting
Banjul, Gambia
Contact: Sarah Rowland-Jones, MD     220 4495442     s.rowland-jones@mrc.gm    
Contact: Tumani Corrah, PhD     220 4495442     tcorrah@mrc.gm    
Sub-Investigator: Francis Akor, MD            
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 Laboratories, Gambia
Principal Investigator: Kalifa Bojang, MD Medical Research Council
  More Information

Study ID Numbers: SCC1089, GMP_PII_6
Study First Received: November 20, 2007
Last Updated: November 20, 2007
ClinicalTrials.gov Identifier: NCT00561899  
Health Authority: Gambia: MRC Ethics Committee

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

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

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

ClinicalTrials.gov processed this record on January 15, 2009