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

NCT00561899 | Completed Phase 2 DMC

• 2 other identifiers: SCC1089GMP_PII_6
• Study Type: interventional
• Target: 1,295
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

safety; tolerability; efficacy; intermittent prevetive treatment; children

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children

  Onset of IPT to end of malaria season

Secondary Outcomes (1)

• The efficacy of the three drug regimens when used for seasonal IPT in children

  Onset of IPT to end of malaria season

Study Arms (3)

1

EXPERIMENTAL

SP+AQ

Drug: SP, amodiaquine, piperaquine, dihdroartemisinin

2

EXPERIMENTAL

Piperaquine plus SP arm

Drug: intermittent preventive treatment

3

EXPERIMENTAL

Du-Cotecxin

Drug: Du-Cotecxin

Interventions

SP, amodiaquine, piperaquine, dihdroartemisinin DRUG

once every month during september, October and November

Also known as: Fansidar, Du-Cotecxin

1

intermittent preventive treatment DRUG

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

Also known as: SP, Du-Cotecxin

2

Du-Cotecxin DRUG

Du-Cotecxin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days

Also known as: SP

3

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Department of State for Health and Social Welfare, The Gambia: collaborator

Study Sites (1)

Medical Research Council Laboratories,

Banjul, The Gambia

Location

Related Publications (1)

• Bojang K, Akor F, Bittaye O, Conway D, Bottomley C, Milligan P, Greenwood B. A randomised trial to compare the safety, tolerability and efficacy of three drug combinations for intermittent preventive treatment in children. PLoS One. 2010 Jun 21;5(6):e11225. doi: 10.1371/journal.pone.0011225.

  PMID: 20574538 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquine; piperaquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kalifa Bojang, MD

  Medical Research Council Unit, The Gambia

  PRINCIPAL INVESTIGATOR

• Kalifa Bojang, MD

  Medical Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

TH (1)