Clinical trial
Efficacy and Safety of Chloroquine for Plasmodium Vivax in the Philippines in 2016.
Name
2003-25-12_2016
Description
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.
Trial arms
Trial start
2016-01-04
Estimated PCD
2016-12-29
Trial end
2016-12-29
Status
Completed
Treatment
Chloroquine
Chloroquine will be administered according to body weight at a total dose of 25 mg base/kg over 3 days (10 mg base/kg on Day 0; 10 mg base/kg on Day 1 and 5 mg base/kg on Day 2). Correct drug dosage will be determined using the dosing chart (in accordance
Arms:
Patients detected with Plasmodium vivax (Chloroquine)
Primaquine
For Pf patients, primaquine at 0.75 mg base/kg body weight single dose will be given on Day 3 for Pf patients; For Pv patients primaquine will be withheld for 28 days and will be given after Day 28 follow-up, at 0.25 mg base/kg per day for 14 days.
Arms:
Patients detected with Plasmodium vivax (Chloroquine)
Size
74
Primary endpoint
Number of Patients with Early Treatment Failure (ETF)
Day 1-3
Number of Patients with Late Clinical Failure (LCF)
Day 4-28
Number of Patients with Late Parasitological Failure (LPF)
Day 7-28
Number of Patients with Adequate Clinical and Parasitological Response (ACPR)
Day 0-28
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Capillary blood (malaria blood film and filter paper)'}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}
Updated at
2023-07-25
1 organization
2 products
3 indications
Organization
Research Institute for Tropical MedicineProduct
ChloroquineIndication
MalariaIndication
Malaria caused by Plasmodium vivaxIndication
RecrudescenceProduct
Primaquine