Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children
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ClinicalTrials.gov Identifier: NCT01464138 |
Recruitment Status :
Completed
First Posted : November 3, 2011
Last Update Posted : November 3, 2011
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This is an open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children.
The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Condition or disease | Intervention/treatment | Phase |
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Malaria | Drug: Fosmidomycin and Clindamycin co-administration | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
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Experimental: Fosmidomycin-Clindamycin
Single arm study. Co-administration of Fosmidomycin and Clindamycin.
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Drug: Fosmidomycin and Clindamycin co-administration
Fosmidomycin sodium syrup at a concentration of 250mg/5ml and clindamycin hydrochloride syrup at a concentration of 75mg/5ml. Administered 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) |
- Day 28 cure rate >95% [ Time Frame: 28 days ]
- Day 7 cure rate of 100% [ Time Frame: Day 6 ]
- Parasite Clearance Time [ Time Frame: 0-7 days ]
- Fever Clearance Time [ Time Frame: 0-7 days ]

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Ages Eligible for Study: | 6 Months to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male subjects aged six months to three years
- Female subjects aged six months to three years
- Body weight >5kg
- 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
Exclusion Criteria:
- Symptoms/signs of severe malaria, according to WHO criteria
- Body weight <5kg
- Other plasmodial infections (P vivax, P ovale, P malariae)
- Severe malnutrition with weight for age <60% 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
- Haemoglobin <7g/dl
- Adequate anti-malarial treatment within previous 7 days
- Inability to tolerate oral therapy
- Parent or guardian deemed to be unsupportive
- On co-trimoxazole prophylaxis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464138
Mozambique | |
Centro de Investigacao em Saude da Manhica | |
Maputo, Mozambique |
Principal Investigator: | Quique Bassat, PhD | CRESIB, Barcelona |
Responsible Party: | Jomaa Pharma GmbH |
ClinicalTrials.gov Identifier: | NCT01464138 |
Other Study ID Numbers: |
JP012 |
First Posted: | November 3, 2011 Key Record Dates |
Last Update Posted: | November 3, 2011 |
Last Verified: | November 2011 |
Malaria |
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Clindamycin Clindamycin palmitate |
Clindamycin phosphate Fosmidomycin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |