EfficacyPhase 4CQ+PQNCT06044805

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

A Phase 4 study testing Chloroquine and Primaquine in people with Efficacy and Malaria, run by Dinka Dugassa at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 months and older
Conditions the study is for: Efficacy, Malaria, Chloroquine
What is being tested?: Chloroquine and Primaquine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteEthiopia
Study dates: 19 Dec 2022to 15 Mar 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

Shecha Health Center
Arba Minch, South Ethiopia

Other trials in Ethiopia

About this study

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

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.

Read the 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.

Conditions: Efficacy, Malaria, Chloroquine, Vivax Malaria
Being tested: Chloroquine, Primaquine
Keywords: Therapeutic, Efficacy, Chloroquine, Primaquine, Ethiopia
Medical subject headings: Malaria, Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChloroquineDrug
Also called Chloroquine base, Chloroquine Phosphate
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)
PrimaquineDrug
Primaquine: 7.5 mg base tablet. Medication given as 0.25mg/kg daily for 14 days.

Study groups in NCT06044805
Study group	Role	What they receive
Therapeutic Efficacy of Chloroquine Plus Primaquine	Experimental	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. Receives: Drug: Chloroquine; Drug: Primaquine

What is being measured

The primary outcome is the main question the study is designed to answer.

Early treatment failure [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.
Measured: within the first 3 days
Late Clinical Failure (LCF)
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.
Measured: 42 days
Late Parasitological Failure (LPF)
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.
Measured: 42 days
Adequate Clinical and Parasitological Response (ACPR)
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.
Measured: 42 days

Secondary outcomes (5)

The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.
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.
Measured: 42 days
The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.
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.
Measured: 42 days
The secondary outcome of this study is determining fever clearance rate based on fever clearance time.
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).
Measured: 42 days
The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.
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.
Measured: 42 days
The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.
This study's secondary goal was evaluating the incidence of adverse events in 42 follow-up period.
Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 202215 Mar 2023

First posted21 Sep 2023
Study start19 Dec 2022
Primary completion13 Mar 2023
Study completion15 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for EfficacyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06044805
Sponsor's protocol ID: EPHI-IRB-294-2
Acronym: CQ+PQ
Status last verified: Sep 2023
First submitted: 6 Jul 2023
Last updated: 22 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fekadu G, Dugassa D, Negera GZ, Woyessa TB, Turi E, Tolossa T, Fetensa G, Assefa L, Getachew M, Shibiru T. Self-Medication Practices and Associated Factors Among Health-Care Professionals in Selected Hospitals of Western Ethiopia. Patient Prefer Adherence. 2020 Feb 20;14:353-361. doi: 10.2147/PPA.S244163. eCollection 2020.
PubMed 32110001
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.
PubMed 34336132
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.
PubMed 33552517
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.
PubMed 33299558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06044805
Acronym / sponsor ID: CQ+PQ / EPHI-IRB-294-2
Conditions: Efficacy, Malaria, Chloroquine, Vivax Malaria
Keywords: Therapeutic, Efficacy, Chloroquine, Primaquine, Ethiopia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Dinka DugassaUniversity, hospital or other
Collaborators: Ethiopian Public Health Institute
Study start: 19 Dec 2022 (actual)
Primary completion: 13 Mar 2023 (actual)
Study completion: 15 Mar 2023 (actual)
First posted: 21 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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

Arm	Type	Receives
Therapeutic Efficacy of Chloroquine Plus Primaquine	Experimental	Drug: Chloroquine, Drug: PrimaquineAn 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.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (12 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChloroquineAlso: Chloroquine base, Chloroquine PhosphateTotal of 25mg base per kg over 3 days (10 mg base/kg on Days 0 and 1, 5 mg base/kg on Day 2)	Drug	Therapeutic Efficacy of Chloroquine Plus Primaquine
PrimaquinePrimaquine: 7.5 mg base tablet. Medication given as 0.25mg/kg daily for 14 days.	Drug	Therapeutic Efficacy of Chloroquine Plus Primaquine

Primary outcome

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.
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.
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.
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.

5 secondary outcomes

The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.
Time frame: 42 days
The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.
Time frame: 42 days
The secondary outcome of this study is determining fever clearance rate based on fever clearance time.
Time frame: 42 days
The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.
Time frame: 42 days
The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.
Time frame: 42 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
Background: PubMed 32110001Fekadu G, Dugassa D, Negera GZ, Woyessa TB, Turi E, Tolossa T, Fetensa G, Assefa L, Getachew M, Shibiru T. Self-Medication Practices and Associated Factors Among Health-Care Professionals in Selected Hospitals of Western Ethiopia. Patient Prefer Adherence. 2020 Feb 20;14:353-361. doi: 10.2147/PPA.S244163. eCollection 2020.
Results publication: PubMed 34336132Fekadu 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.
Results publication: PubMed 33552517Bekele 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.
Results publication: PubMed 33299558Fekadu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bockretsion Gidey study director

Ethiopian Public Health Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Chloroquine and Primaquine in people with Efficacy and Malaria, run by Dinka Dugassa at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early treatment failure [Time Frame: within the first 3 days] (time frame: within the first 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06044805, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.