IPT and Efficacy of Sulphadoxine/Pyrimethamine and Chlorproguanil/Dapsone in 6-59 Month Old Children With Malaria.

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Intermittent Preventive Treatment of malaria in infants is a promising strategy to reduce incidence of clinical malaria in children under the age of 1 year. It is likely to be implemented as a malaria control strategy in Tanzania using sulfadoxine/pyremethamine SP. SP is failing as a first line treatment for clinical episodes of malaria and government policy is driving a change to use Artemesin Combination Therapy (ACT). The main ongoing Kilimanjaro IPTi study is looking at alternatives to SP for use in IPTi. Currently, as there is no evidence for the use of other drugs for IPT, SP will be continued for IPT in pregnancy and in infants. This study proposes to measure the efficacy of SP and chlorproguanil/dapsone (CD), in symptomatic 6- 59 month old children using standard methodology. These are both study drugs in the main IPTi study. This will help us to see how the efficacies of SP and CD in sick children relate to the efficacies for treating asymptomatic children with IPTi. In addition this proposal aims to test the efficacy of SP given to 2-10 month old asymptomatic infants (the target group for IPTi). Evidence suggests that asymptomatic malaria infections with low parasitaemia have a higher cure rate than symptomatic infections with high parasitaemia even when markers of resistance are highly prevalent. This second study aims to quantify this difference and will produce evidence to help policy makers know when drugs used for IPTi should be changed. Both studies will be open label and run concurrently in Hale, Korogwe district near to the main Kilimanjaro IPTi site in Tanzania.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gates Malaria Partnership; London School of Hygiene and Tropical Medicine
• Treatments: Chlorproguanil; Dapsone; Fanasil, pyrimethamine drug combination; Proguanil; Pyrimethamine; Sulfadoxine

Criteria

For 6-59 month study

Inclusion Criteria:

• Aged 6-59 months

• Weight of 4.5 Kgs or greater.

• Not enrolled in IPTi trial

• Absence of severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of WHO reference values, or who has symmetrical edema involving at least the feet)

• A slide-confirmed infection with P. falciparum only

• Initial parasite density between 2,000 and 200,000 asexual parasites per microliter.

• Absence of general danger signs among children < 5 years (see below) Measured axillary temperature ³37.5 °C

• Ability to attend stipulated follow-up visits

• Informed consent provided by parent/guardian

• Absence of history of hypersensitivity reactions to any of the drugs being evaluated

Exclusion Criteria:

• Enrolled in IPTi trial

• Severe malnutrition (defined as above)

• No slide confirmed infection with P. falciparum

• Initial parasite density < 2,000 or > 200,000 asexual parasites per microliter.

• Presence of general danger signs among children < 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions

• Measured axillary temperature <37.5 °C

• Inability to attend stipulated follow-up visits

• Informed consent not provided by parent/guardian

• History of hypersensitivity reactions to any of the drugs being evaluated

For 2-10 month study

Inclusion criteria.

• Aged 2-10 months

• Weight of 4.5 Kgs or greater.

• Not enrolled in IPTi trial

• Absence of severe malnutrition

• A slide-confirmed infection with P. falciparum only

• Any parasite density assessed by research microscopists.

• Absence of general danger signs among children < 5 years (inability to drink or breastfeed; vomiting everything; recent history of convulsions; lethargy or unconsciousness; inability to sit or stand up) or other signs of severe and complicated falciparum malaria according to WHO definitions

• Measured axillary temperature < 37.5 °C

• Ability to attend stipulated follow-up visits

• Informed consent provided by parent/guardian

• Absence of history of hypersensitivity reactions to SP.

Exclusion criteria are not listed separately in the WHO protocol, as they are the opposite of the inclusion criteria.