Clinical trial NCT06044805: Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Efficacy
Malaria
Chloroquine
Vivax Malaria
Keywords: Therapeutic
Efficacy
Chloroquine
Primaquine
Ethiopia
Lead sponsor: Wollega University
Sponsor class: OTHER
Collaborators: name: Ethiopian Public Health Institute
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label clinical trial study will be conducted in Shecha Health Center from December 2022 to March 2023. Participants will be selected and treated with a 25 mg/kg standard dose of chloroquine over three days and a 0.25 mg/kg standard dose of primaquine over fourteen days. Clinical, parasitologic, and hematologic parameters will be monitored for up to a 42-day follow-up period, which will be used to evaluate therapeutic efficacy of CQ+PQ. Thick and thin blood smears will be prepared and examined to determine parasite clearance, and clinical examination will be performed over 42 follow up periods. Haemoglobin level will be measured on days 0, 14, 28 and 42. WHO double-entry Excel sheet will be used for KaplanMeier survival analysis and SPSS version-26 software will be used to analyse the data. All comparisons will be performed at 95% confidence interval and a significance level of 0.05, Pvalue of \<0.05 will be considered statistically significant
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early treatment failure [Time Frame: within the first 3 days]
timeFrame: within the first 3 days
measure: Late Clinical Failure (LCF)
timeFrame: 42 days
measure: Late Parasitological Failure (LPF)
timeFrame: 42 days
measure: Adequate Clinical and Parasitological Response (ACPR)
timeFrame: 42 days
Secondary outcomes:
measure: The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.
timeFrame: 42 days
measure: The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.
timeFrame: 42 days
measure: The secondary outcome of this study is determining fever clearance rate based on fever clearance time.
timeFrame: 42 days
measure: The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.
timeFrame: 42 days
measure: The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.
timeFrame: 42 days
Other outcomes:
Locations:
city: Arba Minch
country: Ethiopia
facility: Shecha Health Center
state: South Ethiopia
Study officials:
affiliation: Ethiopian Public Health Institute
name: Bockretsion Gidey
role: STUDY_DIRECTOR
References:
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citation: Fekadu G, Bekele F, Tolossa T, Fetensa G, Turi E, Getachew M, Abdisa E, Assefa L, Afeta M, Demisew W, Dugassa D, Diriba DC, Labata BG. Impact of COVID-19 pandemic on chronic diseases care follow-up and current perspectives in low resource settings: a narrative review. Int J Physiol Pathophysiol Pharmacol. 2021 Jun 15;13(3):86-93. eCollection 2021.
citation: Bekele F, Fekadu G, Bekele K, Dugassa D, Sori J. Drug-related problems among patients with infectious disease admitted to medical wards of Wollega University Referral Hospital: Prospective observational study. SAGE Open Med. 2021 Jan 22;9:2050312121989625. doi: 10.1177/2050312121989625. eCollection 2021.
citation: Fekadu G, Turi E, Kasu T, Bekele F, Chelkeba L, Tolossa T, Labata BG, Dugassa D, Fetensa G, Diriba DC. Impact of HIV status and predictors of successful treatment outcomes among tuberculosis patients: A six-year retrospective cohort study. Ann Med Surg (Lond). 2020 Nov 15;60:531-541. doi: 10.1016/j.amsu.2020.11.032. eCollection 2020 Dec.