A study investigating the efficacy of artemisinin combination therapy to prevent postpartum malaria and as a treatment for uncomplicated malaria in young infants.

Phase 4

Recruiting

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12620000942954
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-21
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Postpartum study (Main trial)
i) >=18 years of age
ii) Peripheral blood slide negative for malaria at delivery (slide positive women will receive conventional artemether-lumefantrine treatment and are not eligible for recruitment).
ii) They have not received a study intervention in the previous 4 weeks.
iii) They have not required medical/surgical intervention for complications during delivery, other than an episiotomy and broad spectrum antibiotic treatment.
iv) They have no significant co-morbidity
v) They can attend follow-up assessments over the full 6 months

Infant study (Sub-study 2)
i) infant born to Main trial study mother within the last 6 months.
ii) positive blood slide or polymerase chain reaction positive for malaria during the 6 months' follow-up

Exclusion Criteria

i) < 18 years of age
ii) Husband/ father do not grant informed consent (as per Papua New Guinean custom)
iii) Participant has a positive malaria blood slide or rapid diagnostic test at time of delivery.
iv) Participant has a pre-term delivery
v) Neonate demonstrating signs of illness or low APGAR score at delivery
vi)Participant has received treatment with a study intervention in the past 4 weeks.
vii) Participant has signs of a significant concomitant disease including malnutrition, tuberculosis, and pneumonia.
viii) Surgical intervention was required during delivery.
vi) Participant residence is outside health centre catchment area.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of malaria infection in postpartum women will be assessed by malaria microscopy of blood smear samples (Main trial).<br>[4, 8, 12, 16, 20 and 24 weeks (primary timepoint) after intervention commencement, or upon symptomatic presentation during the 6 month follow-up period. ];Incidence of malaria infection in postpartum women will be assessed by polymerase chain reaction (Main trial).[4, 8, 12, 16, 20 and 24 weeks (primary timepoint) after intervention commencement, or upon symptomatic presentation during the 6 month follow-up period. ]