Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax (CQ+PQ)

September 19, 2023 updated by: Dinka Dugassa

Monitoring Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Based on Clinical, Parasitologic and Hematologic Parameters in Shecha Health Center: Open Label Clinical Trial

The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia.

The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter.

Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria.

This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia. The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter.

Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria.

This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • South Ethiopia
      • Arba Minch, South Ethiopia, Ethiopia
        • Shecha Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 6 months
  • Slide confirmed infection with P. vivax with > 250 asexual forms/μl
  • Lives within 5 km of the enrolling health facility
  • Weight ≥ 5.0 kg
  • Ability to swallow oral medication
  • Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule
  • Informed consent from patient or from a parent or guardian in the case of children

Exclusion Criteria:

  • Sever malaria with complication sign and symptoms
  • Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean, symmetrical edema involving at least the feet, or mid-upper arm circumference <100 cm for children less than five years of age
  • Mixed plasmodium infection
  • Severe anemia, defined as hemoglobin (Hb) < 5 g/dl
  • Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration)
  • Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
  • Positive pregnancy test or breastfeeding
  • Unable or unwilling to take contraceptives for women of child-bearing age
  • Children weighing less than 5 kilograms
  • History of hypersensitivity reaction to any medication tested or used as an alternative treatment
  • Participants with history of prolonged QT conditions
  • Taking regular medication, which may interfere with antimalarial pharmacokinetics or efficacy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Efficacy of Chloroquine Plus Primaquine

An invivo single arm trial. Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1(10mg/kg) and 2 (5mg/kg). Total dose, 25 mg base/kg.

Primaquine - it was given once a day (0.25 mg/kg) for fourteen 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.
Drug: Chloroquine
Total of 25mg base per kg over 3 days (10 mg base/kg on Days 0 and 1, 5 mg base/kg on Day 2)
Other Names:
  • Chloroquine Phosphate
  • Chloroquine base
Drug: Primaquine
Primaquine: 7.5 mg base tablet. Medication given as 0.25mg/kg daily for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early treatment failure [Time Frame: within the first 3 days]
Time Frame: within the first 3 days
Danger signs or severe malaria on day 1, day 2 or day 3 in the presence of parasitemia;Parasitemia on day 2 higher than on day 0, irrespective of axillary temperature;Parasitemia on day 3 with axillary temperature ≥37.5 ºC;Parasitemia on day 3 ≥25% of count on day 0.
within the first 3 days
Late Clinical Failure (LCF)
Time Frame: 42 days
Danger signs or severe malaria in the presence of parasitemia on any day between day 4 and 42 in patients who did not previously meet any of the criteria of Early Treatment Failure; Presence of parasitemia on any day between 4 and day 42 with axillary temperature ≥37.5 °C (or history of fever) in patients who did not previously meet any of the criteria of Early Treatment Failure.
42 days
Late Parasitological Failure (LPF)
Time Frame: 42 days
Presence of parasitemia on any day between day 7 and day 42 and axillary temperature <37.5 ºC in patients who did not previous meeting any of the criteria of Early Treatment Failure or Late Clinical Failure.
42 days
Adequate Clinical and Parasitological Response (ACPR)
Time Frame: 42 days
Absence of parasitemia on day 42 irrespective of axillary temperature, in patients who did not previously meet any of the criteria of Early Treatment Failure, Late Clinical Failure, or Late Parasitological Failure.
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.
Time Frame: 42 days
This study's secondary goal was to calculate the parasite clearance rate based on parasite clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.
42 days
The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.
Time Frame: 42 days
This study's secondary goal was to calculate the gametocyte clearance rate based on gametocyte clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.
42 days
The secondary outcome of this study is determining fever clearance rate based on fever clearance time.
Time Frame: 42 days
Calculating the fever clearance rate based on fever clearance time was the secondary outcome of this clinical trial. Fever clearance time is calculated using hours, days, weeks, and months. Temperatures less than 37.5 degrees celsius (T 37.5oC) are deemed to be fever-free(fever cleared) while temperatures greater than or equal to 37.5 degrees celsius (T>37.5oC) are classified as having fever (fever not cleared).
42 days
The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.
Time Frame: 42 days
Calculating the mean hemoglobin change overtime in the 42 study period based on hemoglobin concentration at D0, D14, D28 and D42 was the secondary outcome of this clinical trial. Milligrammes per deciliter are used to measure the concentration of haemoglobin.
42 days
The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.
Time Frame: 42 days
This study's secondary goal was evaluating the incidence of adverse events in 42 follow-up period.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dinka Dugassa

Collaborators

Ethiopian Public Health Institute

Investigators

  • Study Director: Bockretsion Gidey, Ethiopian Public Health Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPHI-IRB-294-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malaria

Clinical Trials on Chloroquine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe