Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria (NCT02198807) | Clinical Trial Compass
UnknownPhase 2
Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria
100 participantsStarted 2014-03
Plain-language summary
The objective of this study is to explore the role of fosmidomycin and piperaquine as non-artemisinin-based combination therapy for acute uncomplicated Plasmodium falciparum when administered over three days.
Together, fosmidomycin and piperaquine fulfil the WHO criteria for combination therapy by meeting the three key parameters of having different modes of action and different biochemical targets while exhibiting independent blood schizonticidal activity. Like the artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active against existing drug-resistant parasites. Piperaquine has a long half life protecting fosmidomycin as a much shorter lived molecule against selection of resistant parasites and will provide post-treatment prophylaxis.
Who can participate
Age range
1 Year – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects aged 1 to 60 years inclusive
* Body weight between 5kg and 90kg inclusive
* Acute manifestations of a mono-infection with Plasmodium falciparum as determined by either a rapid diagnostic test for adults or microscopically confirmed by an asexual parasitaemia of 1,000 to 150,000/uL and fever with an axillary temperature of \> 37.5 degress C or oral/rectal/tympanic temperature of \> 38.0 degrees C or history of fever during the previous 72 hours
* Compliance with contraceptive measures throughout the study period of 63 days in females of child bearing potential
Exclusion Criteria:
To be eligible for inclusion in the study, subjects must NOT meet any of the following criteria:
* Signs of severe/complicated malaria according to WHO criteria
* Pregnancy as excluded by negative serum human chorionic gonadotrophin (hCG) test
* Lactation
* Mixed Plasmodium infection
* Severe vomiting on three or more occasions in the previous 24 hours
* Severe diarrhoea on four or more occasions in the previous 24 hours
* Concomitant disease masking assessment of response including
* abnormal liver function tests with bilirubin \> 40 µmol/L, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) levels \> x 2 upper limit of normal
* impaired renal function with creatinine level \> x 2 upper limit of normal
* haemoglobin level \< 7.5g/dl
* white cell count \> 12000/µL
* History of cardiovascular disease including arrhythmia wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.