Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection

NCT02691910 | Completed Phase 2

• 2 other identifiers: 404067/2012-3550.565
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized open-label trial to evaluate the efficacy of chloroquine (CQ) alone compared to chloroquine+primaquine (CQ+PQ) in the treatment of uncomplicated malaria caused by Plasmodium vivax infection in a endemic area in the westernmost part of the Amazon Basin of Brazil. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was 28 days. The duration of complete follow up to detect recurrent P. vivax infections by passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ treatment (3.5mg/kg total dose) starting on day 28 of the study follow-up.

Conditions

Malaria, Vivax

Keywords

malaria; Plasmodium vivax; treatment; Chloroquine; Primaquine

Outcome Measures

Primary Outcomes (1)

• Early treatment failure

  danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia OR parasitaemia on day 2 higher than on day 0 OR parasitaemia on day 3 with axillary temperature ≥ 37.5 ºC OR parasitaemia on day 3 ≥ 25% of count on day 0

  within the first 3 days

Secondary Outcomes (2)

• Late clinical failure

  28 days

• Late parasitological failure

  28 days

Other Outcomes (2)

• Adverse Event

  180 days

• Adverse Reaction

  180 days

Study Arms (2)

CONCURRENT CHLOROQUINE+PRIMAQUINE

ACTIVE COMPARATOR

The infected individuals were treated with the standard chloroquine (CQ)+primaquine(PQ) regimen to malaria caused by Plasmodium vivax. * Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1 (7.5mg/kg) and 2 (7.5mg/kg). Total dose, 25 mg base/kg. * Primaquine - it was given once a day (0.5 mg/kg) for seven 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; Drug: Primaquine

CHLOROQUINE

EXPERIMENTAL

The infected individuals were initially treated with chloroquine (CQ) alone and the primaquine(PQ) was introduced on day 28. * Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1 (7.5mg/kg) and 2 (7.5mg/kg). Total dose, 25 mg base/kg. * Primaquine - it was given once a day (0.5 mg/kg) for seven days, starting on day 28 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

Interventions

Chloroquine DRUG

10mg/kg on day 0 and 7.5mg/kg on days 1 and 2. Total dose, 25 mg base/kg. Tablet containing 150mg of base.

Also known as: Chloroquine diphosphate

CHLOROQUINE; CONCURRENT CHLOROQUINE+PRIMAQUINE

Primaquine DRUG

0.5 mg/kg once a day, for seven days. Total dose, 3.5mg/kg.

CONCURRENT CHLOROQUINE+PRIMAQUINE

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:

• Slide-confirmed mono-infection with P. vivax
• Age \> 5 years
• Ability to swallow oral medication
• Axillary temperature ≥ 37.5º C or history of fever during the previous 48 hours
• Patient or caregiver agrees to comply with the study protocol (including blood collections and return visits) and provides written informed consent.

You may not qualify if:

• General danger signs or symptoms of severe malaria requiring hospitalization
• Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values)
• Slide-confirmed co-infection with any other Plasmodium species
• Severe anemia, defined as Hg\<8g/100 ml
• Known hypersensitivity to any of the drugs being evaluated
• Presence of febrile conditions caused by diseases other than malaria
• Serious or chronic medical condition by history (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
• Pregnant or breastfeeding women
• Prior history of hemolysis or severe anemia
• Regular medication which may interfere with antimalarial pharmacokinetics

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• University of Sao Paulo: collaborator

Study Sites (2)

Oswaldo Cruz Foundation

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

Institute of Biomedical Sciences, University of Sao Paulo

São Paulo, São Paulo, 05508-900, Brazil

Location

Related Publications (24)

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  PMID: 30782991 DERIVED

MeSH Terms

Conditions

Malaria, Vivax; Malaria

Interventions

Chloroquine; chloroquine diphosphate; Primaquine

Condition Hierarchy (Ancestors)

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

Study Officials

• MARCELO U FERREIRA, MD-PHD

  Biomedical Sciences Institute of São Paulo University

  STUDY DIRECTOR

• SIMONE L ANDRADE, MD-PHD

  Oswaldo Cruz Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)