Efficacy and safety of Praziquantel for treatment of Plasmodium falciparum infection in asymptomatic Gabonese adults

Phase 2

• Conditions: Malaria

• Registration Number: PACTR202206584817951

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Subject male or female with age = 18 years

• Plasmodium parasitaemia with 200 to 5000 parasites/µL

• Asymptomatic malaria defined by: presence of Plasmodium parasites with absence of fever (axillary temperature = 37.5 ° C or oral / tympanic temperature = 38 ° C, or absence of history of fever in recent 24 hours and the week before inclusion).

• Signed and written informed consent

• Willingness not to take drugs or substances which could have an impact on praziquantel blood levels

• Women only: Must agree to practice continuous contraception for the duration of the study. Those methods include: combined (estrogen and progestogen containing) hormonal contraception, associated with inhibition of ovulation, oral, intravaginal or transdermal progestogen-only hormonal contraception associated with inhibition of ovulation, oral, injectable, implantable intrauterine device (IUD), intrauterine hormonereleasingsystem (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence and use of condoms.

Exclusion Criteria

• Signs and symptoms of complicated malaria / severe malaria

• Taking an experimental drug in the last 4 weeks.

• Any antimalarial treatment in the last 4 weeks

• Is using and intends to continuing using a medication known to cause drug reactions with artemether/lumefantrine (e.g. cimetidine, metoclopramide, antacids, kaolin, terfenadine etc.)

• Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin).

• Use of praziquantel within 30 days of study enrolment.

• Previous (within the last 10 years) participation in a malaria vaccine study

• Moderate to severe anemia (Hemoglobin level < 8 g/dL)

• Known history of hepatic disease or liver damage

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection

• Use of immunoglobulins or blood products within 3 months prior to enrolment

• Contraindications or known allergy to praziquantel or the first-line anti-malarial medication artemether/lumefantrine, or known or suspected allergy or intolerance to any other ingredient of the drug products (IMP/Non-IMP)

• Severe malnutrition (Body Mass Index (BMI) < 16.0)

• Pregnancy, lactation or intention to become pregnant during the study

• Known history of sickle cell anaemia, sickle cell trait, thalassemia or thalassemia trait

• Participants unable to be closely followed for social, geographic or psychological reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified