Status:
TERMINATED
IPT and Efficacy of Sulphadoxine/Pyrimethamine and Chlorproguanil/Dapsone in 6-59 Month Old Children With Malaria.
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Malaria
Eligibility:
All Genders
2-59 years
Phase:
PHASE3
Brief 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...
Detailed Description
Introduction and Rational This is part of a multicentre trial looking into antimalarial resistance within a series of Intermittent Preventive Treatment of malaria in Infants (IPTi) studies. IPTi is a...
Eligibility Criteria
Inclusion
- For 6-59 month study
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00361114
Start Date
July 1 2006
End Date
October 1 2007
Last Update
January 26 2017
Active Locations (1)
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1
Hale Dispensary
Korogwe, Tanga, Tanzania