EFFICACY AND SAFETY OF PYRONARIDINE-ARTESUNATE (PYRAMAX) FOR THE TREATMENT OF FALCIPARUM MALARIA IN AFRICAN PREGNANT WOME

Phase 3

Completed

• Conditions: Malaria

• Registration Number: PACTR202011812241529
• Lead Sponsor: niversity of Sciences Techniques and Technologies of Bamako

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-24
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 1875

Inclusion Criteria

1.Gestation =16 weeks and <37 weeks as assessed by ultrasound when possible, uterine height or late menstrual period;
2.P. falciparum mono-infection (by microscopy) of any density, regardless of symptoms and HIV status;
3.Haemoglobin =7g/dL;
4.Age: =15 years;
5.Residence within the health facility catchment area;
6.Willing to adhere to study requirements and to deliver at the health facility.
7. Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, the investigator is responsible to check that the woman herself is also freely willing to take part in the study).
8.For the PK study women should be on first line anti-retroviral treatment (efavirenz-based both in DRC and Mozambique) for at least 6 months.

Exclusion Criteria

1.Known allergy to the study drugs;
2.History of known pregnancy complications or poor obstetric history such as repeated stillbirths or eclampsia;
3.History or presence of major illnesses likely to influence pregnancy outcome;
4.Any significant illness at the time of screening requiring hospitalization, including
a.Severe malaria;
b.Any sign or symptom suggesting hepatic lesions (e.g. nausea with abdominal pain and icterus) or severe liver disease classified as B or C by the Child-Pugh score;
c.Known history or evidence of clinically significant cardiovascular disorders or family history of long QT syndrome.
5.Intent to move out of the study catchment area before delivery or delivery out of the catchment area;
6.Prior enrolment in the study;
7.Clear evidence of recent (1 week) treatment with antimicrobials with antimalarial activity (azithromycin, clindamycin, tetracycline, quinolones, cotrimoxazole and SP); For HIV-infected pregnant women to be included in the PK sub-study, cotrimoxazole use is not an exclusion criterion.
8.Twin/multiple pregnancy;
9.Known history of G6PD deficiency or sickle cell disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified