MalariaPhase 2NCT00217451
Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin
A Phase 2 study testing Fosmidomycin-clindamycin in people with Malaria, run by Albert Schweitzer Hospital at 1 site in Gabon.
Trial summary
Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. Read more about this study
- Who is it for?
- Ages 12 months to 14 years
- Conditions the study is for
- Malaria
- What is being tested?
- Fosmidomycin-clindamycin
- How many people
- 51 participants
- Where
- 1 siteGabon
- Study dates
- Jun 2002to Mar 2003
- 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 12 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Uncomplicated P. falciparum malaria with acute manifestation
- Asexual parasitemia between 1,000-100,000/μL
- Body weight between 5-65 kg
- Ability to tolerate oral therapy
- Informed consent, oral agreement of the child if appropriate
- Residence in the study area for the duration of at least 4 weeks
Who cannot join
- Adequate anti-malarial treatment within the previous 7 days
- Antibiotic treatment for a concurrent infection
- Haemoglobin <7g/dL
- Hematocrit <25%
- Leukocyte count >15,000/μL
- Mixed plasmodial infection
Show all 9Show fewer
- Severe malaria, any other severe underlying disease
- Concomitant disease masking assessment of treatment response
- Inflammatory bowel disease, and any other disease causing fever.
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Medical Research Unit, Lambaréné
Lambaréné, Moyen-Ogooué Province, B.P. 118
About this study
Official title: Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. A previous small study has shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of malaria parasites. The current study will evaluate the efficacy and safety of the combination given for three days in children with uncomplicated malaria in Gabon.
Read the detailed description
The treatment of malaria is becoming increasingly difficult due to the development of Plasmodium falciparum strains resistant to commonly used antimalarials. Fosmidomycin was shown to be well tolerated and fast-acting in paediatric outpatients and adults, but late recrudescences preclude its use as monotherapy. Clindamycin was identified as a suitable combination partner following the demonstration of synergistic inhibition of plasmodial growth by in vitro and animal studies.
In this study, the safety and efficacy of fosmidomycin-clindamycin (30 mg/kg plus 10 mg/kg) twice daily for three days is assessed in children with acute uncomplicated P. falciparum malaria.
- Conditions
- Malaria
- Being tested
- Fosmidomycin-clindamycin
- Keywords
- Malaria, Fosmidomycin, Clindamycin, Gabon
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosmidomycin-clindamycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients cured by day 14
Incidence of adverse events after the start of treatment
Secondary outcomes (3)
Parasite clearance time
Fever clearance time
PCR corrected day 28 cure rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2002
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 51 participants
Sponsor and investigators
- Lead sponsor
- Albert Schweitzer Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Steffen Borrmann, MD, Principal investigator, Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, KenyaPeter G. Kremsner, MD, FRCP, Principal investigator, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217451
- Sponsor's protocol ID
- 06/2002/FOS-CLIN/JP006
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Publications
Beytia ED, Porter JW. Biochemistry of polyisoprenoid biosynthesis. Annu Rev Biochem. 1976;45:113-42. doi: 10.1146/annurev.bi.45.070176.000553. No abstract available.
PubMed 9026Lois LM, Campos N, Putra SR, Danielsen K, Rohmer M, Boronat A. Cloning and characterization of a gene from Escherichia coli encoding a transketolase-like enzyme that catalyzes the synthesis of D-1-deoxyxylulose 5-phosphate, a common precursor for isoprenoid, thiamin, and pyridoxol biosynthesis. Proc Natl Acad Sci U S A. 1998 Mar 3;95(5):2105-10. doi: 10.1073/pnas.95.5.2105.
PubMed 9482846Rohmer M, Knani M, Simonin P, Sutter B, Sahm H. Isoprenoid biosynthesis in bacteria: a novel pathway for the early steps leading to isopentenyl diphosphate. Biochem J. 1993 Oct 15;295 ( Pt 2)(Pt 2):517-24. doi: 10.1042/bj2950517.
PubMed 8240251Jomaa H, Wiesner J, Sanderbrand S, Altincicek B, Weidemeyer C, Hintz M, Turbachova I, Eberl M, Zeidler J, Lichtenthaler HK, Soldati D, Beck E. Inhibitors of the nonmevalonate pathway of isoprenoid biosynthesis as antimalarial drugs. Science. 1999 Sep 3;285(5433):1573-6. doi: 10.1126/science.285.5433.1573.
PubMed 10477522Clinical study report for Protocol JP 001 - Evaluation of fosmidoymcin in adult patients with acute uncomplicated Plasmodium falciparum malaria. 2001. World Health Organisation, Geneva, Switzerland and Jomaa Pharmaka GmbH, Germany
Wiesner J, Henschker D, Hutchinson DB, Beck E, Jomaa H. In vitro and in vivo synergy of fosmidomycin, a novel antimalarial drug, with clindamycin. Antimicrob Agents Chemother. 2002 Sep;46(9):2889-94. doi: 10.1128/AAC.46.9.2889-2894.2002.
PubMed 12183243
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT00217451
- Acronym / sponsor ID
- 06/2002/FOS-CLIN/JP006
- Conditions
- Malaria
- Keywords
- Malaria, Fosmidomycin, Clindamycin, Gabon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants
- Lead sponsor
- Albert Schweitzer HospitalUniversity, hospital or other
- Study start
- Jun 2002
- Study completion
- Mar 2003
- First posted
- 22 Sep 2005 (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.
Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. A previous small study has shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of malaria parasites. The current study will evaluate the efficacy and safety of the combination given for three days in children with uncomplicated malaria in Gabon.
Detailed description
The treatment of malaria is becoming increasingly difficult due to the development of Plasmodium falciparum strains resistant to commonly used antimalarials. Fosmidomycin was shown to be well tolerated and fast-acting in paediatric outpatients and adults, but late recrudescences preclude its use as monotherapy. Clindamycin was identified as a suitable combination partner following the demonstration of synergistic inhibition of plasmodial growth by in vitro and animal studies.
In this study, the safety and efficacy of fosmidomycin-clindamycin (30 mg/kg plus 10 mg/kg) twice daily for three days is assessed in children with acute uncomplicated P. falciparum malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Uncomplicated P. falciparum malaria with acute manifestation
- Asexual parasitemia between 1,000-100,000/μL
- Body weight between 5-65 kg
- Ability to tolerate oral therapy
- Informed consent, oral agreement of the child if appropriate
Key exclusion criteria (9 listed)
- Adequate anti-malarial treatment within the previous 7 days
- Antibiotic treatment for a concurrent infection
- Haemoglobin <7g/dL
- Hematocrit <25%
- Leukocyte count >15,000/μL
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-clindamycin | Drug | – |
Primary outcome
Proportion of patients cured by day 14
Incidence of adverse events after the start of treatment
3 secondary outcomes
Parasite clearance time
Fever clearance time
PCR corrected day 28 cure rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
- Background: PubMed 9026Beytia ED, Porter JW. Biochemistry of polyisoprenoid biosynthesis. Annu Rev Biochem. 1976;45:113-42. doi: 10.1146/annurev.bi.45.070176.000553. No abstract available.
- Background: PubMed 9482846Lois LM, Campos N, Putra SR, Danielsen K, Rohmer M, Boronat A. Cloning and characterization of a gene from Escherichia coli encoding a transketolase-like enzyme that catalyzes the synthesis of D-1-deoxyxylulose 5-phosphate, a common precursor for isoprenoid, thiamin, and pyridoxol biosynthesis. Proc Natl Acad Sci U S A. 1998 Mar 3;95(5):2105-10. doi: 10.1073/pnas.95.5.2105.
- Background: PubMed 8240251Rohmer M, Knani M, Simonin P, Sutter B, Sahm H. Isoprenoid biosynthesis in bacteria: a novel pathway for the early steps leading to isopentenyl diphosphate. Biochem J. 1993 Oct 15;295 ( Pt 2)(Pt 2):517-24. doi: 10.1042/bj2950517.
- Background: PubMed 10477522Jomaa H, Wiesner J, Sanderbrand S, Altincicek B, Weidemeyer C, Hintz M, Turbachova I, Eberl M, Zeidler J, Lichtenthaler HK, Soldati D, Beck E. Inhibitors of the nonmevalonate pathway of isoprenoid biosynthesis as antimalarial drugs. Science. 1999 Sep 3;285(5433):1573-6. doi: 10.1126/science.285.5433.1573.
- BackgroundClinical study report for Protocol JP 001 - Evaluation of fosmidoymcin in adult patients with acute uncomplicated Plasmodium falciparum malaria. 2001. World Health Organisation, Geneva, Switzerland and Jomaa Pharmaka GmbH, Germany
- Background: PubMed 12183243Wiesner J, Henschker D, Hutchinson DB, Beck E, Jomaa H. In vitro and in vivo synergy of fosmidomycin, a novel antimalarial drug, with clindamycin. Antimicrob Agents Chemother. 2002 Sep;46(9):2889-94. doi: 10.1128/AAC.46.9.2889-2894.2002.
- General information on malaria at the website of the Malaria Foundation InternationalLink provided by the sponsor.
- Homepage of Medical Research Unit, LambarénéLink provided by the sponsor.
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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.
Steffen Borrmann, MD principal investigator
Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, Kenya
Peter G. Kremsner, MD, FRCP principal investigator
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-clindamycin in people with Malaria, run by Albert Schweitzer Hospital 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 9 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: finished, as of the sponsor's last update on 22 Sep 2005. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients cured by day 14. The study lists 2 primary outcomes in all. 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 NCT00217451, which also lists 6 linked publications.
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 22 Sep 2005.