Three Alternative Drug Regimens for Malaria Seasonal Preventive Treatment in Senegal

May 26, 2010 updated by: London School of Hygiene and Tropical Medicine

Randomized Trial of Effectiveness and Acceptability of Three Alternative Regimens for Malaria Seasonal Intermittent Preventive Treatment in Senegal

The purpose of this trial is to compare the acceptability, efficacy and safety of three alternative drug regimens for use for seasonal Intermittent Preventive Treatment to prevent malaria in children. Children aged 2 months to 5 years will be randomized to receive IPT with one of three regimens during the transmission season: sulfadoxine-pyrimethamine (SP) plus amodiaquine, show to be highly effective for IPT in a recent trial; SP plus piperaquine, used for malaria prophylaxis in China for many years; or Duocotexcin (a combination of piperaquine with an artemisinin).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In areas of seasonal malaria transmission the burden of severe disease and mortality due to malaria is mainly among children under 5 years of age. Intermittent preventive treatment (IPT) with antimalarial drugs given to all children once a month during the transmission season is a promising new strategy for malaria prevention. Seasonal IPT with sulfadoxine-pyrimethamine (SP) and one dose of artesunate resulted in a 90% reduction in incidence of clinical malaria in a recent trial in Senegal (Cisse et al., Lancet 2006). An important consideration is the possible impact of seasonal IPT on the emergence and spread of drug resistant parasite genotypes, the choice of drug regimen is therefore critical. A second trial in Senegal showed that a combination of two non-artemisinin drugs with relatively long half lives (SP and amodiaquine (AQ) over three days) was more effective than SP with artesunate and more effective than AQ with artesunate, in preventing malaria; and very few children developed parasitaemia, so that the potential for drug resistant genotypes to emerge and spread was low. Although SP+AQ was more efficacious than the artemisinin-containing regimens tested, it was associated with a higher frequency of adverse events, especially vomiting, and AQ has a bitter unpleasant taste, and therefore we have concerns about the acceptability of AQ for widespread use for IPT. It is important to select a drug regimen that is not only effective but safe and acceptable to the community. Each treatment is a 3-dose regimen over 3 days, the first dose will be supervised and the other 2 doses given by the mother or carer. One month after each treatment round, children will be visited at home to check for malaria symptoms, children with fever or a history of fever in the last 48 hours will be asked to give a finger prick blood sample for malaria diagnosis. One month after the last treatment all children will be asked to give a finger prick blood sample for parasitology and haemoglobin, axillary temperature will be measured. The child's carer will be interviewed about compliance and adverse events. The endpoints will be the cumulative incidence of malaria, the proportion of children experiencing moderate and severe adverse events, compliance with and acceptability of the regimen, the prevalence of parasitaemia, and the proportion of children carrying parasite genotypes associated with resistance to sulfadoxine or pyrimethamine at the end of the transmission season. Since acceptability is difficult to assess in the formal setting of a trial, and because the method of delivery may affect compliance and acceptability, drug treatments will be delivered by community workers replicating the conditions under IPT would be delivered routinely in Senegal. Treatments will be administered at home by local community workers, each worker covering a circuit of approximately 60-80 children. The community worker circuit will be the unit of randomization, for simplicity in the field to minimise allocation errors, and to avoid contamination due to sharing of tablets within a household.

Study Type

Interventional

Enrollment (Actual)

1833

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Senegal
      • Dakar, Senegal
        • Departement de Parasitologie et Mycologie, Universite Cheikh Anta Diop

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 2 to 59 months in September 2007

Exclusion Criteria:

  • history of allergy to study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
sulfalene pyrimethamine plus amodiaquine
Drug: sulfalene-pyrimethamine plus amodiaquine
Monthly treatments during the malaria transmission season
Other Names:
  • Dualkin
Active Comparator: 2
dihydroartemisinin piperaquine
Drug: dihydroartemisinin plus piperaquine
Monthly treatments during the transmission season
Other Names:
  • Duo cotexcin
Active Comparator: 3
sulfadoxine-pyrimethamine plus piperaquine
Drug: sulfadoxine pyrimethamine plus piperaquine
Monthly treatments during the malaria transmission season
Other Names:
  • sulfadoxine pyrimethamine
  • piperaquine phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of malaria
Time Frame: Four months
Four months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events reported by the mother: vomiting, headache, fever, nausea, diarrhea
Time Frame: within 4 days of the start treatment
within 4 days of the start treatment
Prevalence of P.falciparum parasitaemia
Time Frame: Measured by microscopy 1 month after the last treatment, in December
Measured by microscopy 1 month after the last treatment, in December
Haemoglobin concentration
Time Frame: Measured 1 month after the last treatment, in December
Measured 1 month after the last treatment, in December
The proportion of children carrying P.falciparum genotypes associated with resistance to sulfadoxine and pyrimethamine
Time Frame: Measured in December
Measured in December
Compliance with the treatment regimen
Time Frame: Recorded 4 days after the start of treatment
Recorded 4 days after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Cheikh Anta Diop University, Senegal

Investigators

  • Principal Investigator: Badara Cisse, PhD, Universite CHeikh Anta Diop

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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