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NCT Number: NCT06044805

Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax

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.

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Key information

Conditions

Efficacy Chloroquine Infections Malaria Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases Vivax Malaria

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shecha Health Center

Arba Minch, South Ethiopia, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloroquine

Drug

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 base, Chloroquine Phosphate

Primaquine

Drug

Primaquine: 7.5 mg base tablet. Medication given as 0.25mg/kg daily for 14 days.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Dinka Dugassa

Other

Collaborators

  • Ethiopian Public Health Institute

Registry information

Official study title

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

Acronym: CQ+PQ

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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