Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine (PQ) for the Treatment of Uncomplicated Plasmodium Vivax Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Early treatment failure
研究概览
简要总结
This is a randomized open-label trial to evaluate the efficacy of chloroquine (CQ) alone compared to chloroquine+primaquine (CQ+PQ) in the treatment of uncomplicated malaria caused by Plasmodium vivax infection in a endemic area in the westernmost part of the Amazon Basin of Brazil. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was 28 days. The duration of complete follow up to detect recurrent P. vivax infections by passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ treatment (3.5mg/kg total dose) starting on day 28 of the study follow-up.
详细描述
- OBJECTIVE- To assess the efficacy of co-administered chloroquine+primaquine (CQ+PQ) vs.CQ alone (PQ being postponed up to day 28 of CQ therapy) as a schizontocidal therapy (28-day follow-up) and as radical cure among uncomplicated P. vivax malaria (6-month follow-up). Specifically:
- To measure the clinical and parasitological efficacy of CQ+PQ vs. CQ alone, over 28 days of follow-up.
- To measure the time to the first recurrent vivax malaria episode, between days 29 and 180 of follow-up.
- METHODS - This is a randomized, open-label. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was 28 days. The duration of complete follow up to detect recurrent P. vivax infections by passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ (3.5mg/kg total dose) starting on day 28 of the follow-up.
2.1 STUDY SITE AND POPULATION - The study was carried out in the city of Cruzeiro do Sul , Acre State, in the westernmost part of the Amazon Basin of Brazil. The study population was patients aged above 5 years diagnosed with uncomplicated P. vivax malaria, who gave permission for study inclusion.
2.2 INCLUSION CRITERIA - mono-infection with P. vivax, age >5 years, ability to swallow oral medication, axillary temperature ≥37.5ºC (or history of fever in the last 48 hours) or to agree to comply with the study and provides written informed consent.
2.3 EXCLUSION CRITERIA FOR ENROLLMENT - severe malaria requiring hospitalization, severe malnutrition (weight-for-age ≤ 3 standard deviations below the mean), co-infection with any other Plasmodium species, severe anemia (Hg<8g/100 ml), hypersensitivity to CQ or PQ, febrile conditions caused by diseases other than malaria, serious or chronic medical condition, pregnant or breastfeeding women, prior history of hemolysis or severe anemia or regular medication which may interfere with antimalarial pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Slide-confirmed mono-infection with P. vivax
- •Age > 5 years
- •Ability to swallow oral medication
- •Axillary temperature ≥ 37.5º C or history of fever during the previous 48 hours
- •Patient or caregiver agrees to comply with the study protocol (including blood collections and return visits) and provides written informed consent.
排除标准
- •General danger signs or symptoms of severe malaria requiring hospitalization
- •Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values)
- •Slide-confirmed co-infection with any other Plasmodium species
- •Severe anemia, defined as Hg<8g/100 ml
- •Known hypersensitivity to any of the drugs being evaluated
- •Presence of febrile conditions caused by diseases other than malaria
- •Serious or chronic medical condition by history (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
- •Pregnant or breastfeeding women
- •Prior history of hemolysis or severe anemia
- •Regular medication which may interfere with antimalarial pharmacokinetics
研究组 & 干预措施
CONCURRENT CHLOROQUINE+PRIMAQUINE
The infected individuals were treated with the standard chloroquine (CQ)+primaquine(PQ) regimen to malaria caused by Plasmodium vivax.
- Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1 (7.5mg/kg) and 2 (7.5mg/kg). Total dose, 25 mg base/kg.
- Primaquine - it was given once a day (0.5 mg/kg) for seven days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
干预措施: Chloroquine (Drug)
CONCURRENT CHLOROQUINE+PRIMAQUINE
The infected individuals were treated with the standard chloroquine (CQ)+primaquine(PQ) regimen to malaria caused by Plasmodium vivax.
- Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1 (7.5mg/kg) and 2 (7.5mg/kg). Total dose, 25 mg base/kg.
- Primaquine - it was given once a day (0.5 mg/kg) for seven days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
干预措施: Primaquine (Drug)
CHLOROQUINE
The infected individuals were initially treated with chloroquine (CQ) alone and the primaquine(PQ) was introduced on day 28.
- Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1 (7.5mg/kg) and 2 (7.5mg/kg). Total dose, 25 mg base/kg.
- Primaquine - it was given once a day (0.5 mg/kg) for seven days, starting on day 28 of CQ treatment. Total dose, 3.5mg/kg.
The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
干预措施: Chloroquine (Drug)
结局指标
主要结局
Early treatment failure
时间窗: within the first 3 days
danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia OR parasitaemia on day 2 higher than on day 0 OR parasitaemia on day 3 with axillary temperature ≥ 37.5 ºC OR parasitaemia on day 3 ≥ 25% of count on day 0
次要结局
- Late parasitological failure(28 days)
- Late clinical failure(28 days)