Three Alternative Drug Regimens for Malaria Seasonal Preventive Treatment in Senegal

NCT00529620 | Completed Phase 3 DMC

• 1 other identifier: 5184
• Study Type: interventional
• Target: 1,833
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Malaria

Keywords

Malaria; IPT; preventive treatment

Outcome Measures

Primary Outcomes (1)

• Incidence of malaria

  Four months

Secondary Outcomes (5)

• Adverse events reported by the mother: vomiting, headache, fever, nausea, diarrhea

  within 4 days of the start treatment

• Prevalence of P.falciparum parasitaemia

  Measured by microscopy 1 month after the last treatment, in December

• Haemoglobin concentration

  Measured 1 month after the last treatment, in December

• The proportion of children carrying P.falciparum genotypes associated with resistance to sulfadoxine and pyrimethamine

  Measured in December

• Compliance with the treatment regimen

  Recorded 4 days after the start of treatment

Study Arms (3)

1

ACTIVE COMPARATOR

sulfalene pyrimethamine plus amodiaquine

Drug: sulfalene-pyrimethamine plus amodiaquine

2

ACTIVE COMPARATOR

dihydroartemisinin piperaquine

Drug: dihydroartemisinin plus piperaquine

3

ACTIVE COMPARATOR

sulfadoxine-pyrimethamine plus piperaquine

Drug: sulfadoxine pyrimethamine plus piperaquine

Interventions

sulfalene-pyrimethamine plus amodiaquine DRUG

Monthly treatments during the malaria transmission season

Also known as: Dualkin

1

dihydroartemisinin plus piperaquine DRUG

Monthly treatments during the transmission season

Also known as: Duo cotexcin

2

sulfadoxine pyrimethamine plus piperaquine DRUG

Monthly treatments during the malaria transmission season

Also known as: sulfadoxine pyrimethamine, piperaquine phosphate

3

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 2 to 59 months in September 2007

You may not qualify if:

• history of allergy to study drugs

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Cheikh Anta Diop University, Senegal: collaborator

Study Sites (1)

Departement de Parasitologie et Mycologie, Universite Cheikh Anta Diop

Dakar, Senegal

Location

Related Publications (1)

• Cisse B, Cairns M, Faye E, NDiaye O, Faye B, Cames C, Cheng Y, NDiaye M, Lo AC, Simondon K, Trape JF, Faye O, NDiaye JL, Gaye O, Greenwood B, Milligan P. Randomized trial of piperaquine with sulfadoxine-pyrimethamine or dihydroartemisinin for malaria intermittent preventive treatment in children. PLoS One. 2009 Sep 28;4(9):e7164. doi: 10.1371/journal.pone.0007164.

  PMID: 19784374 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquine; artenimol; 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

• Badara Cisse, PhD

  Universite Cheikh Anta Diop

  PRINCIPAL INVESTIGATOR

• Paul J Milligan, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 27, 2010

Record last verified: 2010-05

Locations

SE (1)