ARTEMETHER-LUMEFANTRINE VERSUS ARTESUNATE- AMODIAQUINE IN PREGNANT WOME

Not Applicable

• Conditions: Malaria; Pregnancy and Childbirth

• Registration Number: PACTR201310000484185
• Lead Sponsor: kah Chukwuemeka Marcel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1.Symptoms of malaria such as fever (T 37.5oc), headaches, body pains within 24 hours before presentation.
2.Microscopically-confirmed P. falciparum malaria with parasitaemia of at least one plus (1-10 parasites/100 thick film field).
3.Consent to participate in the study
4.Willingness/ability to comply with follow-up schedule

Exclusion Criteria

1.Severe malaria or danger signs of severe malaria (e.g. loss of consciousness, convulsions, anuria)
2.Women in the first trimester of pregnancy
3.Use of any anti-malarial drug other than sulphadoxine pyrimethamine less than 7 days before presentation
4.Other concurrent pregnancy related diseases e.g. urinary tract infections.
5.History of reaction to any of the drugs.
6.Patients not tolerating orally.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the efficacy of the artemether/lumefantrine and artesunate amodiaquine fixed dose combinations in pregnant women with acute uncomplicated falciparum malaria

Secondary Outcome Measures

Name	Time	Method
To assess the pregnancy outcome in these women