TES of Chloroquine for Pv in the Philippines in 2016

NCT05958797 | Completed DMC FDA Drug

• 1 other identifier: 2003-25-12_2016
• Study Type: observational
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malaria; Vivax Malaria; Recrudescence

Keywords

malaria; TES; Plasmodium vivax; Chloroquine

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Patients detected with Plasmodium vivax (Chloroquine)

Patients with mono-infection of Plasmodium falciparum with ≥ 250 per µl

Drug: Chloroquine; Drug: Primaquine

Interventions

Chloroquine DRUG

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

Patients detected with Plasmodium vivax (Chloroquine)

Primaquine DRUG

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.

Patients detected with Plasmodium vivax (Chloroquine)

Eligibility Criteria

• Age: 6 Months - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population of interest consists of patients aged between \> 6 months to 59 years old diagnosed with uncomplicated vivax malaria attending the study health clinic, and having given, or whose parents or legal guardians have given informed consent for study inclusion and assent in children as appropriate.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute for Tropical Medicine, Philippines: lead
• World Health Organization: collaborator

Related Publications (2)

• Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics. 2002 Oct;(182):17-23.

  PMID: 14983848 BACKGROUND

• 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.

  PMID: 24141714 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Capillary blood (malaria blood film and filter paper)

MeSH Terms

Conditions

Malaria; Malaria, Vivax; Recurrence

Interventions

Chloroquine; Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fe Esperanza Caridad J Espino, MD, PhD

  Research Institute for Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Parasitology Department

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 25, 2023
• Study Start: January 4, 2016
• Primary Completion: December 29, 2016
• Study Completion: December 29, 2016
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data information will be provided upon request
• Access Criteria: Data Transfer