Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil

NCT03610399 | Completed Results

• 1 other identifier: 7061
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

We plan to assess the efficacy of 3 different regimens of chloroquine and primaquine for the treatment of P. vivax infections in Cruzeiro do Sul, Acre, Brazil. Patients will be divided in 3 different groups: treatment with regular dose of primaquine (0.5 mg/kg per day for 7 days) with directly observed therapy; regular dose of primaquine without directly observed therapy; and increased total dose of primaquine (0.5 mg/kg per day for14 days) with directly observed therapy. All patients will receive chloroquine (CQ) for three days at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National Malaria Control guidelines. Clinical and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and for a total period of 168 days (24 weeks) to evaluate chances of recrudescence, relapse, or reinfection. Results from this drug efficacy study will be used to assist the Brazilian Ministry of Health in assessing their national malaria treatment policy for P. vivax malaria.

Conditions

P Vivax; Malaria, Vivax

Keywords

treatment response; efficacy; primaquine; chloroquine

Outcome Measures

Primary Outcomes (2)

• Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled

  Participants with adequate clinical and parasitologic response among patients enrolled, meaning patients who did not fail treatment by day 28. Those are participants who at day 28 did not present clinical deterioration or presence of parasitemia.

  28 days

• Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled

  Participants with adequate clinical and parasitologic response among patients enrolled, meaning patients who did not fail treatment by day 168. Those are participants who at day 168 did not present clinical deterioration or presence of parasitemia.

  168 days

Secondary Outcomes (1)

• Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168

  168 days

Study Arms (3)

Primaquine Regular Dose Unsupervised

OTHER

This is the regular primaquine dose Brazil without directly observed therapy.

Drug: Primaquine

Primaquine Regular Dose Supervised

ACTIVE COMPARATOR

This is the regular primaquine dose in Brazil but with directly observed therapy.

Drug: Primaquine

Primaquine Double Dose Unsupervised

ACTIVE COMPARATOR

This is the double total primaquine dose (14 days) in Brazil with directly observed therapy.

Drug: Primaquine

Interventions

Primaquine DRUG

Different total dose and supervision.

Also known as: Primaquine dose

Primaquine Double Dose Unsupervised; Primaquine Regular Dose Supervised; Primaquine Regular Dose Unsupervised

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥5 years 2. Body weight \<120 kg 3. Documented fever (axillary temperature ≥37.5o C) or history of fever during the previous 48 hours in the absence of another obvious cause of fever, such as pneumonia, otitis media, etc 4. Monoinfection with P. vivax with parasitemia between 100 and 200,000 asexual parasites/µl as determined by microscopic examination of thick and thin peripheral blood smears 5. Informed consent from the patient or parent/guardian (for those \<18 years), assent from child (ages 7 to 17 years inclusive), patients 5 through 6 years old will not need an assent 6. Willingness on the part of the patient to return to the clinic and/or receive home visits for regular check-ups during the 24-week (168 days) follow-up period 7. Place of residence within 30-45 minutes of study site.

You may not qualify if:

• \. Presence of malaria danger signs
• Unable to drink
• Vomiting (more than twice in the previous 24 hours)
• Recent history of convulsions (one or more in the previous 24 hours)
• Impaired consciousness
• Unable to sit or stand 2. Presence of signs of severe malaria (WHO criteria)
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• Cerebral malaria (unarousable coma)
• Renal failure (serum creatinine \>3 mg/dL or clinical signs)
• Pulmonary edema
• Hypoglycemia (blood glucose \<40mg/dL or clinical signs)
• Shock (systolic blood pressure \<70 mm Hg in adults; 50 mm Hg in children)
• Spontaneous bleeding/disseminate intravascular coagulation
• Repeated generalized convulsions
• Acidemia/acidosis (clinical signs)

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Ministry of Health, Brazil: collaborator
• Evandro Chagas National Institute of Infectious Disease: collaborator

Study Sites (1)

Hospital do Jurua

Cruzeiro do Sul, Brazil

Location

Related Publications (1)

• Chamma-Siqueira NN, Negreiros SC, Ballard SB, Farias S, Silva SP, Chenet SM, Santos EJM, Pereira de Sena LW, Povoa da Costa F, Cardoso-Mello AGN, Marchesini PB, Peterka CRL, Viana GMR, Macedo de Oliveira A. Higher-Dose Primaquine to Prevent Relapse of Plasmodium vivax Malaria. N Engl J Med. 2022 Mar 31;386(13):1244-1253. doi: 10.1056/NEJMoa2104226.

  PMID: 35353962 DERIVED

MeSH Terms

Conditions

Malaria, Vivax

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Suiane Negreiros
• Organization: Acre Health State Secretariat

omsvalle@hotmail.com

55 68 9983 1266

Study Officials

• Alexandre Macedo de Oliveira, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: We plan to compare 3 different regimens of primaquine for P. vivax treatment.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: August 1, 2018
• Study Start: April 9, 2018
• Primary Completion: March 12, 2019
• Study Completion: March 12, 2019
• Last Updated: August 9, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)