Oral Treatment of Acute Uncomplicated Plasmodium Falciparum MalariaPhase 2FOSPIPNCT02198807
Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria
A Phase 2 study testing Fosmidomycin-Piperaquine in people with Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria, run by Jomaa Pharma GmbH.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- Fosmidomycin-Piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 with QTc interval ≥ 450msec, respiratory disease including active tuberculosis, hepatic disease including jaundice, renal failure, malignancy, neurological disorders including convulsions and psychiatric disturbances
- History of immunological disease including Hepatitis A, B and C and HIV-AIDS
- Severe malnutrition
- History of hypersensitivity or adverse reactions to fosmidomycin, piperaquine, artesunate and mefloquine
- Treatment with antimalarial and antibacterial agents within the previous 28 days
About this study
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
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.
- Being tested
- Fosmidomycin-Piperaquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosmidomycin-PiperaquineDrug
| Study group | Role | What they receive |
|---|---|---|
| Fosmidomycin-Piperaquine | Experimental | 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 Receives: Drug: Fosmidomycin-Piperaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per protocol, PCR-corrected cure rate on Day 28
Six-hourly asexual counts until negative on three successive occasions.
Weekly smears on days 7, 14, 21 and 28
Measured: 28 days
Secondary outcomes (6)
Per protocol, PCR-corrected cure rates on Day 7 and Day 63
Weekly smears on days 35 +/- 3 days, 42 +/- 3 days and 63 +/- 3 days
Measured: 63 days
Derived parasite reduction ratio at 48 hours
Six-hourly asexual counts until negative on three successive occasions
Measured: 2 days
Parasite clearance time
Six-hourly asexual counts until negative on three successive occasions
Measured: 96 hours
Fever clearance time
Six hourly temperature recordings until normal on three successisve occasions
Measured: 96 hours
Proportion of subjects with gametocytes on Day 7
Smear on Day 7
Measured: 7 days
Adverse event recording
Recording of vital signs and ECG monitoring
Recording of incidence, severity, drug-relatedness and seriousness of AEs and laboratory abnormalites
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Treatment of Acute Uncomplicated Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jomaa Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche Médicale de Lambaréné
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198807
- Sponsor's protocol ID
- JP017
- Acronym
- FOSPIP
- Status last verified
- Jun 2015
- First submitted
- 22 Jul 2014
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mombo-Ngoma G, Remppis J, Sievers M, Zoleko Manego R, Endamne L, Kabwende L, Veletzky L, Nguyen TT, Groger M, Lotsch F, Mischlinger J, Flohr L, Kim J, Cattaneo C, Hutchinson D, Duparc S, Moehrle J, Velavan TP, Lell B, Ramharter M, Adegnika AA, Mordmuller B, Kremsner PG. 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. Clin Infect Dis. 2018 Jun 1;66(12):1823-1830. doi: 10.1093/cid/cix1122.
PubMed 29293893
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02198807
- Acronym / sponsor ID
- FOSPIP / JP017
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jomaa Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche Médicale de Lambaréné
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fosmidomycin-Piperaquine | Experimental | Drug: Fosmidomycin-PiperaquineFosmidomycin 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 |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosmidomycin-Piperaquine | Drug | Fosmidomycin-Piperaquine |
Primary outcome
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
6 secondary outcomes
Per protocol, PCR-corrected cure rates on Day 7 and Day 63
Time frame: 63 days
Derived parasite reduction ratio at 48 hours
Time frame: 2 days
Parasite clearance time
Time frame: 96 hours
Fever clearance time
Time frame: 96 hours
Proportion of subjects with gametocytes on Day 7
Time frame: 7 days
Adverse event recording
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Derived from this study: PubMed 29293893Mombo-Ngoma G, Remppis J, Sievers M, Zoleko Manego R, Endamne L, Kabwende L, Veletzky L, Nguyen TT, Groger M, Lotsch F, Mischlinger J, Flohr L, Kim J, Cattaneo C, Hutchinson D, Duparc S, Moehrle J, Velavan TP, Lell B, Ramharter M, Adegnika AA, Mordmuller B, Kremsner PG. 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. Clin Infect Dis. 2018 Jun 1;66(12):1823-1830. doi: 10.1093/cid/cix1122.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosmidomycin-Piperaquine in people with Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria, run by Jomaa Pharma GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per protocol, PCR-corrected cure rate on Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.