BridgeMD
Antimalarial prophylactic efficacy of a weekly dose atovaquone-proguanil
EU CTIS ID: 2024-518884-36-00
What this study is testing
The overall primary objective is to evaluate the prophylactic efficacy of a weekly dose administration of oral AP 250/100 mg in non-immune healthy volunteers exposed to malaria by intravenous administration of heterologous PfSPZ Challenge (NF54).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Healthy malaria-naive adults aged 18 to 40 years.
- • Willingness to take AP or placebo at the scheduled timepoint and a curative antimalarial regimen following CHMI and development of amplifying parasitaemia.
- • Answer all questions on the informed consent quiz correctly.
- • Able and willing (in the Investigator’s opinion) to comply with all study requirements
- • Willing to allow the investigators to discuss the volunteer’s medical history with their general practitioner if required.
- • Residence in or nearby Tübingen with a maximum travel time to our study centre of 1 hour for the study period
You likely can't join if
- • History of malaria.
- • History of seizure (except uncomplicated febrile convulsion at childhood)
- • Pregnancy, lactation or intention to become pregnant during the study.
- • Diagnosis of any immune deficiency disorder, including human immunodeficiency virus (HIV) infection.
- • History of (functional) asplenia.
- • Use of chronic (more than 14 days) systemic immunosuppressive medication within the past 2 years (topical or inhaled immunosuppressive agents are allowed).
See the full eligibility criteria
Who can join
- • Healthy malaria-naive adults aged 18 to 40 years.
- • Willingness to take AP or placebo at the scheduled timepoint and a curative antimalarial regimen following CHMI and development of amplifying parasitaemia.
- • Answer all questions on the informed consent quiz correctly.
- • Able and willing (in the Investigator’s opinion) to comply with all study requirements
- • Willing to allow the investigators to discuss the volunteer’s medical history with their general practitioner if required.
- • Residence in or nearby Tübingen with a maximum travel time to our study centre of 1 hour for the study period
- • Women who agree to practice effective contraception for the duration of the study (a method which results in a low failure rate; i.e. less than 1% per year).
- • Weight over 40 kg and BMI ≥19 and ≤ 30.
- • Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local and national blood banking eligibility criteria
- • Provision of written informed consent to receive PfSPZ Challenge (NF54) for CHMI.
- • Reachable (24/7) by mobile phone during the CHMI period.
What rules you out
- • History of malaria.
- • History of seizure (except uncomplicated febrile convulsion at childhood)
- • Pregnancy, lactation or intention to become pregnant during the study.
- • Diagnosis of any immune deficiency disorder, including human immunodeficiency virus (HIV) infection.
- • History of (functional) asplenia.
- • Use of chronic (more than 14 days) systemic immunosuppressive medication within the past 2 years (topical or inhaled immunosuppressive agents are allowed).
- • Any other confirmed or suspected immunosuppressive or immunodeficient state (e.g., repeated and/or unusual infection), including history of infection caused by opportunistic organisms, any infection or combination of infections that suggest underlying immunodeficiency, history of meningitis, encephalitis, septic shock, life-threatening soft tissue infection, more than one pneumonia.
- • Known (or signs consistent with) sickle cell anemia, sickle cell trait, thalassemia or thalassemia trait, glucose-6-phosphate dehydrogenase deficiency.
- • Use of immunoglobulins or blood products within 3 months prior to enrolment.
- • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- • Any other serious chronic illness requiring hospital specialist supervision
- • History of travel to a malaria-endemic country within the previous 12 months.
- • History of serious psychiatric condition that may affect participation in the study
- • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 24 g (men) or 12 g (women) per day.
- • Suspected or known illicit drug abuse in the 5 years preceding enrolment.
- • Volunteers unable to be closely followed for social, geographic or psychological reasons.
- • Any other significant disease, disorder, finding at medical history, biochemistry, haematology tests, urine analysis results, clinical examination or electrocardiogram (ECG) which, in the opinion of the Investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
- • Difficulties with venepuncture for blood sampling at screening visit due to veins that easily collapse or roll, are too thin, or are hard to find.
- • Positive for hepatitis B surface antigen (HBs-antigen).
- • Seropositive for hepatitis C virus (antibodies to HCV).
- • Abnormal vital signs
- • Intake of medication that potentially interferes with the study intervention or rescue drugs
- • Residence in a malaria endemic area for 5 or more years continuously.
- • Prior receipt of malaria vaccine candidates or malaria challenge products.
- • Use of concomitant medication with anti-plasmodial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin erythromycin, fluoroquinolones, or azithromycin).
- • Receipt of an investigational product in the 90 days preceding, or planned receipt during the study period.
- • Contraindication to the use of the following antimalarial medications: AP, artemether-lumefantrine, artesunate.
- • Use of medication interacting with AP (e.g. metoclopramide, tetracycline, rifampicin, rifabutin, efavirenz, or nevirapine).
- • Use of medication interacting with artemether-lumefantrine (e.g. disopyramide, quinidine, procainamide, amiodarone, rifampicin, carbamazepine, phenytoin, phenobarbital, haloperidol, domperidone, pimozide or pipamperone).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.