MalariaPhase 2NCT01361269
Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
A Phase 2 study testing Fosmidomycin and clindamycin in people with Malaria, run by Zentopharm GmbH at 1 site in Gabon.
Trial summary
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Malaria
- What is being tested?
- Fosmidomycin and clindamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGabon
- Study dates
- Jun 2011to Dec 2011
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects aged three to ten years
- Body weight ≥12kg
- Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria
- Asexual parasitaemia between 1,000/µL and 200,000/µL
- Ability to tolerate oral therapy
- Willingness of the parent or guardian to provide informed signed consent
Who cannot join
- Symptoms/signs of severe malaria, according to WHO criteria (see appendix I)
- Body weight <12kg
- Other concomitant plasmodial infections (P vivax, P ovale, P malariae)
- Severe malnutrition with weight for height <70% (according to WHO tables) or clinical kwashiorkor
- Gastro-intestinal disturbance with persistent vomiting (> three episodes within previous 24 hours) and/or diarrhoea (> 5 loose stools in the preceding 24 hours)
- Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment
Show all 12Show fewer
- Packed cell volume (PCV) on arrival <22%
- Adequate anti-malarial treatment within previous 7 days
- Inability to tolerate oral therapy
- Parent or guardian deemed to be unsupportive
- On co-trimoxazole prophylaxis
- Any known allergies to the investigational products
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné
Saadou Issifou, 0024106106256, isaadou2002@yahoo.fr
About this study
Official title: Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.
Read the detailed description
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The goal of this study is to assess a new drug combination, fosmidomycin-clindamycin. The primary objective of the study is to assess and compare the efficacy, safety and tolerance (between sites) of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children in Mozambique and Gabon.
The secondary objective is to differentiate between recrudescent parasitaemia and reinfection in the event of recurrent parasitaemia developing within the 28-day follow-up period, to determine the population pharmacokinetics of fosmidomycin when co-administered orally with clindamycin and to compare the in vitro sensitivity of isolates of Plasmodium falciparum to fosmidomycin.
The trial will include 100 children aged 3-10 years, divided between clinical sites of Gabon and Mozambique.
- Conditions
- Malaria
- Being tested
- Fosmidomycin and clindamycin
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosmidomycin and clindamycinDrug
The study drugs will be co-administered under supervision by a study physician or nurse in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| Fosmidomycin and clindamycin treatment | Experimental | All the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg). Receives: Drug: Fosmidomycin and clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Cure rate at day 28 will be determined by PCR
Measured: Day 28
Secondary outcomes (1)
cure rate
The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zentopharm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Albert Schweitzer Hospital, Centro de Investigacao em Saude de Manhica
- Investigators
- Saadou Issifou, MD PhD, Principal investigator, Medical Research Unit, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361269
- Sponsor's protocol ID
- FosClinChildren
- Status last verified
- May 2011
- First submitted
- 24 May 2011
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children
- ClinicalTrials.gov ID
- NCT01361269
- Acronym / sponsor ID
- FosClinChildren
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zentopharm GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Albert Schweitzer Hospital, Centro de Investigacao em Saude de Manhica
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 26 May 2011 (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.
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.
Detailed description
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The goal of this study is to assess a new drug combination, fosmidomycin-clindamycin. The primary objective of the study is to assess and compare the efficacy, safety and tolerance (between sites) of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children in Mozambique and Gabon.
The secondary objective is to differentiate between recrudescent parasitaemia and reinfection in the event of recurrent parasitaemia developing within the 28-day follow-up period, to determine the population pharmacokinetics of fosmidomycin when co-administered orally with clindamycin and to compare the in vitro sensitivity of isolates of Plasmodium falciparum to fosmidomycin.
The trial will include 100 children aged 3-10 years, divided between clinical sites of Gabon and Mozambique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fosmidomycin and clindamycin treatment | Experimental | Drug: Fosmidomycin and clindamycinAll the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg). |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female subjects aged three to ten years
- Body weight ≥12kg
- Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria
- Asexual parasitaemia between 1,000/µL and 200,000/µL
- Ability to tolerate oral therapy
Key exclusion criteria (12 listed)
- Symptoms/signs of severe malaria, according to WHO criteria (see appendix I)
- Body weight <12kg
- Other concomitant plasmodial infections (P vivax, P ovale, P malariae)
- Severe malnutrition with weight for height <70% (according to WHO tables) or clinical kwashiorkor
- Gastro-intestinal disturbance with persistent vomiting (> three episodes within previous 24 hours) and/or diarrhoea (> 5 loose stools in the preceding 24 hours)
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 and clindamycinThe study drugs will be co-administered under supervision by a study physician or nurse in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg). | Drug | Fosmidomycin and clindamycin treatment |
Primary outcome
Cure rate
Time frame: Day 28
Cure rate at day 28 will be determined by PCR
1 secondary outcome
cure rate
Time frame: day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Saadou Issifou, MD PhD principal investigator
Medical Research Unit, Albert Schweitzer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosmidomycin and clindamycin in people with Malaria, run by Zentopharm GmbH at 1 site in Gabon.
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 6 inclusion and 12 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 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Saadou Issifou, MD PhD (0024106106256, isaadou2002@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2011.