Malaria
Conditions
Interventions
Placebo
Praziquantel
Sponsors
Bernhard Nocht Institut for Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assessment of the proportion of participants with microscopically-determined parasite clearance on D7 after administration of PZQ compared with placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the proportion of participants with =90% parasitemia reduction on D7 compared with baseline between PZQ and placebo study arms | — |
Countries
Gabon
Contacts
Public ContactLidwine Badjina
BNITM
Outcome results
None listed