Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria (FOSPIP)
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|ClinicalTrials.gov Identifier: NCT02198807|
Recruitment Status : Unknown
Verified June 2015 by Jomaa Pharma GmbH.
Recruitment status was: Active, not recruiting
First Posted : July 24, 2014
Last Update Posted : June 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria||Drug: Fosmidomycin-Piperaquine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIa Proof of Concept Study to Explore the Efficacy, Tolerability and Safety of Fosmidomycin Sodium When Administered With Piperaquine Tetraphosphate to Adults and Older Children With Acute Uncomplicated Plasmodium Falciparum Malaria|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||December 2015|
Fosmidomycin sodium capsules 450 mg, dosage: 30mg/kg twice daily for 3 days Piperaquine phosphate tablets 320 mg, dosage: 16 mg/kg once a day for 3 days
- Per protocol, PCR-corrected cure rate on Day 28 [ Time Frame: 28 days ]
Six-hourly asexual counts until negative on three successive occasions.
Weekly smears on days 7, 14, 21 and 28
- Per protocol, PCR-corrected cure rates on Day 7 and Day 63 [ Time Frame: 63 days ]Weekly smears on days 35 +/- 3 days, 42 +/- 3 days and 63 +/- 3 days
- Derived parasite reduction ratio at 48 hours [ Time Frame: 2 days ]Six-hourly asexual counts until negative on three successive occasions
- Parasite clearance time [ Time Frame: 96 hours ]Six-hourly asexual counts until negative on three successive occasions
- Fever clearance time [ Time Frame: 96 hours ]Six hourly temperature recordings until normal on three successisve occasions
- Proportion of subjects with gametocytes on Day 7 [ Time Frame: 7 days ]Smear on Day 7
- Adverse event recording [ Time Frame: 28 days ]
Recording of vital signs and ECG monitoring
Recording of incidence, severity, drug-relatedness and seriousness of AEs and laboratory abnormalites