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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

Status unknown Phase 2 Last updated 12 June 2015
What this trial tests

Phase 2 trial testing Fosmidomycin-Piperaquine in Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in 100 participants. Status unknown.

Timeline
1 March 2014
Primary endpoint
1 July 2014
1 December 2015

Quick facts

Lead sponsorJomaa Pharma GmbH
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment100
Start date1 March 2014
Primary completion1 July 2014
Estimated completion1 December 2015

Drugs / interventions tested

Conditions studied

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.

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. Abstracts of the Eighth EDCTP Forum, 6-9 November 2016.
    · 2017 · cited 1× · PMID 28589036 · DOI 10.1136/bmjgh-2016-000260

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