Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil

Malaria Clinical Trial

— PAACT-PF  

Official title:

A Multi-center, Open-label, Randomized, Phase 4, Trial of Artemether-Lumefantrine and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Falciparum Malaria Parasitemia in Pregnant Women in Brazil

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01082731
• Other study ID #: PAACT-PF
• Status: Terminated
• Phase: Phase 4
• First received: March 8, 2010
• Last updated: April 12, 2012
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Data on the burden of MIP in low transmission areas, such as Latin America, are very limited; there is even less information on the efficacy of case management of MiP. The treatment recommendations for MiP in Latin American countries have been changing rapidly in recent months; currently, either artemether-lumefantrine (AL) or mefloquine-artesunate (MA) is the first line treatment for P. falciparum (depending on country); however, no data exists on the efficacy of these drugs for the treatment of malaria in pregnancy in Latin America to support their use.

We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety and efficacy of the present therapies, AL and MA. We hypothesize that the drugs will both be efficacious for use in pregnant women in Brazil.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

1. Gestational age >16 weeks (determined by LMP and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus

2. Normal fetal heart beat detected by Doppler

3. Presence of any P. falciparum parasitemia = 50,000 parasites/microliter (thick film)

4. Willing to sign or thumb print informed consent

5. Willing to return for scheduled follow up visits for treatment and observation until delivery

6. Willing to deliver in health facility

Exclusion Criteria:

1. Pregnancy < 16 weeks

2. Microscopically confirmed P. vivax or mixed infection/ parasitemia (P. falciparum and another species of Plasmodium, i.e. P. vivax, P. ovale, or P. malariae)

3. History of allergy or hypersensitivity to interventional drugs

4. Exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including AL and MA)

5. Patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin)

6. History or family history of epilepsy or psychiatric disorder

7. Presence of signs and symptoms of severe malaria

8. Hemoglobin < 7 g/dl

9. Inability to tolerate oral medication (repeated vomiting, impairment of consciousness).

10. History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, HIV or AIDS, known hemoglobinopathy

11. Participant's inability to return for follow up visits

12. Age <15 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artemether-Lumefantrine
4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
• Mefloquine- Artesunate
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.

Locations

Country	Name	City	State
Brazil	Hospital Geral Maternidade de Cruzeiro do Sul	Cruzeiro do Sul	Acre
Brazil	Centro de Pesquisa em Patologias Tropicais	Porto Velho	Rondonia

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	63-day PCR-adjusted parasitological cure of P. falciparum		63 days	No