Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Proportion of patients cured by day 14
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Severe malaria, any other severe underlying disease
- •Concomitant disease masking assessment of treatment response
- •Inflammatory bowel disease, and any other disease causing fever.
结局指标
主要结局
Proportion of patients cured by day 14
Incidence of adverse events after the start of treatment
次要结局
- Parasite clearance time
- Fever clearance time
- PCR corrected day 28 cure rate