A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children

Malaria Clinical Trial

— IPTc/ITNs  

Official title:

A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738946
• Other study ID #: IPTCVP17
• Status: Completed
• Phase: N/A
• First received: August 20, 2008
• Last updated: June 3, 2010
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeMali: Ministry of HealthBurkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.

Description:

The trial will be conducted in 6000 children in Burkina Faso and Mali in 2008 and 2009. Each site will enroll 3,000 children. All children will be allocated a long lasting insecticide-treated net and randomized to receive to treatment (amodiaquine + sulfadoxine-pyrimethamine (AQ+SP)) or placebo (AQ-placebo + SP-placebo. Treatment will be administered over 3 rounds during the high malaria transmission season, with one month interval between rounds. Full course treatment of AQ and SP will be administered on each occasion. Treatment will not be given in the second year. Passive surveillance of malaria will be implemented for the monitoring of malaria morbidity and to assess whether children who received intermittent preventive treatment (IPT) are at increased risk of malaria. Adverse events will be monitored during each round of IPT administration. To assess the effect of IPTc on the prevalence of malaria infection, a random sample of 150 children will be visited every week during the high malaria transmission period. This number will be increased to 300 during the low transmission season, but the survey will be reduced to monthly visits. Baseline prevalence of genetic markers of resistance to SP and AQ will be estimated. A second cross-sectional survey will be conducted at the end of the malaria transmission season to assess the effect of IPT on the prevalence of genetic markers of resistance to SP and AQ, on the prevalence of anaemia and on nutritional indicators.

Other known NCT identifiers

• NCT00745979

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 59 Months

Eligibility

Inclusion Criteria:

• Permanent residence in the study area with no intention of leaving during the surveillance period.

• Obtention of informed consent.

Exclusion Criteria:

• Temporary residence in the study area.

• Absence of informed consent.

• Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.

• A history of a previous, significant adverse reaction to either of the study drugs.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Intermittent preventive treatment with AQ+ SP
Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval

Locations

Country	Name	City	State
Burkina Faso	Centre National de Recherche et de Formation sur le Paludisme	Ouagadougou	Kadiogo
Mali	Malaria Research and Training Centre	Bamako

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso, Malaria Research and Training Centre, Mali

Countries where clinical trial is conducted

Burkina Faso,  Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinical malaria		2008-2009	No
Secondary	Incidence of severe malaria, Incidence of anemia, Prevalence of anemia, Prevalence of parasitemia, Proportion of children with parasites carrying resistance markers to AQ and SP, Incidence of hospital admissions due to malaria.		2008-2009	Yes