Malaria Clinical Trial
— TESOfficial title:
Efficacy and Safety of Chloroquine for Plasmodium Vivax in the Philippines in 2016.
Verified date | July 2023 |
Source | Research Institute for Tropical Medicine, Philippines |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Chloroquine (CQ) is officially used as a first-line drug of Plasmodium vivax malaria in the Philippines. In this study, the therapeutic efficacy of CQ for the treatment of uncomplicated P. vivax malaria in three (3) municipalities (Bataraza, Brooke's Point and Rizal) of Palawan was evaluated using the World Health Organization protocol with a follow-up of 28 days and additional 2 days (Day 31 and 34) for hemoglobin monitoring after primaquine treatment. Study subjects were febrile individuals between > 6 months old and 59 years old with confirmed uncomplicated P. vivax infections. Chloroquine was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2), and primaquine following the National Treatment Guidelines. During the 1 year period that this report covers, there were 8,305 individuals were screened.
Status | Completed |
Enrollment | 74 |
Est. completion date | December 29, 2016 |
Est. primary completion date | December 29, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 59 Years |
Eligibility | Inclusion Criteria: - Above 6 months old to 59 years old; - Mono-infection with P. vivax (=250/ul) - Axillary temperature =37.5 °C or oral/rectal temperature of =38 °C; - Glucose-6-dehydrogenase (G6PD) test normal for vivax patients if available - Ability to swallow medication; - Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; - Informed consent from the patient or from a parent or legal guardian in the case of children less than 18 years old; - Informed assent from any minor participant aged 12 - 17 years; and - Consent for pregnancy testing from females of child-bearing potential and from their parent or guardian if under 18 years old. Exclusion Criteria: - Presence of general danger signs among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions - Mixed Plasmodium species; - Presence of severe malnutrition - Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS) - History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Research Institute for Tropical Medicine, Philippines | World Health Organization |
Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics. 2002 Oct;(182):17-23. — View Citation
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients with Early Treatment Failure (ETF) | The number of patients with the following criteria based on microscopy results without PCR:
Development of danger signs or severe malaria on day 1, day 2, or day 3 in the presence of parasitemia; Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature; Parasitaemia on day 3 with axillary temperature =37.5 ºC; Parasitaemia on day 3 =25% of count on day 0. |
Day 1-3 | |
Primary | Number of Patients with Late Clinical Failure (LCF) | The number of patients with the following criteria based on microscopy results without PCR:
Development of danger signs or severe malaria on day 1, day 2, or day 3 in the presence of parasitemia; Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature; Parasitaemia on day 3 with axillary temperature =37.5 ºC; Parasitaemia on day 3 =25% of count on day 0. |
Day 4-28 | |
Primary | Number of Patients with Late Parasitological Failure (LPF) | The number of patients with the presence of parasitemia on any day from day 7 to day 28 and axillary temperature <37.5 ºC, without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure. | Day 7-28 | |
Primary | Number of Patients with Adequate Clinical and Parasitological Response (ACPR) | The number of patients with absence of parasitemia on day 28 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure. | Day 0-28 |
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