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NCT02198807: FOSPIP
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
Phase 2 trial testing Fosmidomycin-Piperaquine in Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in 100 participants. Status unknown.
1 July 2014
Quick facts
| Lead sponsor | Jomaa Pharma GmbH |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 March 2014 |
| Primary completion | 1 July 2014 |
| Estimated completion | 1 December 2015 |
Drugs / interventions tested
- Fosmidomycin-Piperaquine — full drug profile →
Conditions studied
- Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria — all drugs for Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria →
Sponsor
Jomaa Pharma GmbH — full company profile →
Who can join
Adults 1 to 60, any sex, with Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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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
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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The past, present and future of anti-malarial medicines.
Tse EG, Korsik M, Todd MH. · · 2019 · cited 260× · PMID 30902052 · DOI 10.1186/s12936-019-2724-z -
Efficacy and Safety of Fosmidomycin-Piperaquine as Nonartemisinin-Based Combination Therapy for Uncomplicated Falciparum Malaria: A Single-Arm, Age De-escalation Proof-of-Concept Study in Gabon.
Mombo-Ngoma G, Remppis J, Sievers M, Zoleko Manego R, et al · · 2018 · cited 39× · PMID 29293893 · DOI 10.1093/cid/cix1122 -
Whole-Genome Sequencing to Evaluate the Resistance Landscape Following Antimalarial Treatment Failure With Fosmidomycin-Clindamycin.
Guggisberg AM, Sundararaman SA, Lanaspa M, Moraleda C, et al · · 2016 · cited 26× · PMID 27443612 · DOI 10.1093/infdis/jiw304 -
Alternatives to currently used antimalarial drugs: in search of a magic bullet.
Bhagavathula AS, Elnour AA, Shehab A. · · 2016 · cited 19× · PMID 27809883 · DOI 10.1186/s40249-016-0196-8 -
Protecting future antimalarials from the trap of resistance: Lessons from artemisinin-based combination therapy (ACT) failures.
Erhunse N, Sahal D. · · 2021 · cited 17× · PMID 34765267 · DOI 10.1016/j.jpha.2020.07.005 -
FR-900098, an antimalarial development candidate that inhibits the non-mevalonate isoprenoid biosynthesis pathway, shows no evidence of acute toxicity and genotoxicity.
Wiesner J, Ziemann C, Hintz M, Reichenberg A, et al · · 2016 · cited 8× · PMID 27260413 · DOI 10.1080/21505594.2016.1195537 -
Abstracts of the Eighth EDCTP Forum, 6-9 November 2016.
· 2017 · cited 1× · PMID 28589036 · DOI 10.1136/bmjgh-2016-000260
Verify or expand the search:
- PubMed search for NCT02198807
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02198807 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jomaa Pharma GmbH
- Last refreshed: 12 June 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02198807.
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