Intermittent Preventive Treatment of Malaria in Schoolchildren

Malaria Clinical Trial

Official title:

IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852371
• Other study ID #: ITCRVG49
• Secondary ID: LSHTM Ethics 519
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: March 2024
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

Description:

The study will be carried out among children aged ≥ 8 to < 14 years (boys) and ≥ 8 to < 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• Age = 8 to < 14 years (boys), = 8 to < 12 years (girls)

• Student enrolled at participating school in classes 3-7

• Provision of informed consent from parent or guardian

• Provision of assent by student

Exclusion Criteria:

• Known allergy or history of adverse reaction to study medications

• Onset of menstruation (girls)

• Fever (= 37.5°C axillary) or history of fever in the previous 24 hours

• Evidence of severe malaria or danger signs

• Haemoglobin < 7.0 gm/dL

• Parasite density > 10,000/ul

Related Conditions & MeSH terms

• Intermittent Preventive Treatment
• Malaria

Intervention

Drug:
• sulfadoxine-pyrimethamine
25 mg/kg po once on day 0
• amodiaquine + sulfadoxine-pyrimethamine
Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0
• dihydroartemisinin-piperaquine
2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)

Other:
• Placebo
dosed as for amodiaquine (10mg/kg po daily on days 1, 2)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Ministry of Health, Uganda, Uganda Malaria Surveillance Project

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of Parasitaemia (Unadjusted by Genotyping)	Proportion of participants whose thick blood smears that are positive for asexual parasites	after 42 days of follow-up
Secondary	Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment	Proportion of participants whose thick blood smears that are positive with the same asexual parasites at baseline and on the day of failure at genotyping	after 42 days of follow-up
Secondary	Risk of New Infection (Adjusted by Genotyping) in All Participants	Proportion of participants whose thick blood smears that are positive for new asexual parasites on day of failure at genotyping	after 42 days of follow-up
Secondary	Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment	Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up	Over 42 days of follow-up
Secondary	Mean Change in Haemoglobin	Haemoglobin measured in g/dL; Mean change in haemoglobin calculated as the difference in mean haemoglobin (g/dL) on Day 42 - Day 0, in children treated with the different antimalarial regimens	Between day 0 to day 42
Secondary	Risk of Serious Adverse Events	Any untoward medical occurrence in a participant taking study medication after 14 and 42 days of follow up leading to death, disability, hospitalization or extended hospitalization	over 42 days of follow-up
Secondary	Acceptability of IPT Regimens	Perceived willingness to take study medication as routine preventive treatment	on day 7
Secondary	Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment	Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up	after 42 days of follow-up