Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Malaria in Pregnancy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01916954
• Date of registration: 01/08/2013
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Malaria in Pregnancy ALN5P
• Scientific title: Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Pregnant Women in the Democratic Republic of Congo
• Date of first enrolment: July 2013
• Target sample size: 96
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01916954
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Congo

Contacts

• Name: Nicholas P Day, MD PhD
• Affiliation: University of Oxford

Key inclusion & exclusion criteria

Inclusion criteria for non pregnant women:

- Age =18 and = 45 years

- P. falciparum parasitemia = 100 parasites/µL and less than 200.000 parasites/µL

- Hematocrit =21%

- Negative HIV test

- Negative pregnancy test*

- Written informed consent provided

- Willing to stay for 3 or 5 days at the hospital and to comply with the follow-up
schedule

Inclusion criteria for pregnant women (in addition to the above criteria except*):

- Gestational Age = 14 weeks confirmed by ultrasound

- Singleton viable fetus

Exclusion criteria for non-pregnant women:

- Severe malaria or signs of severe malaria

- Medical conditions requiring concomitant drug treatment or transfer to a different
hospital

- Intake of artemether-lumefantrine within the two previous 2 weeks

- Known allergy to the study drugs

- Previous participation in this study or current participation in other studies

Exclusion criteria for pregnant women (in addition to the above criteria):

- Signs of labour

- Fetal abnormalities identified by ultrasound



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: 3-day artemether-lumefantrine

Drug: 5-day artemether-lumefantrine

Primary Outcome(s)

Pharmacokinetics measures [Time Frame: 1 year]

Secondary Outcome(s)

Tolerability and safety measures [Time Frame: 2 years]

Secondary ID(s)

ALN5P

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Kinshasa