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

London School of Hygiene and Tropical Medicine

Status

Completed

Conditions

Malaria

Treatments

Drug: Intermittent preventive treatment with AQ+ SP

Study type

Interventional

Funder types

Other

Identifiers

NCT00738946

IPTCVP17

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,000 estimated patients

Sex

All

Ages

3 to 59 months old

Volunteers

No Healthy Volunteers

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.