The Effect of Chloroquine in the Treatment of Patients With Dengue

February 23, 2009 updated by: University of Sao Paulo
The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Ribeirão Preto, SP, Brazil, 14048.900
        • São Paulo University Medical School at Ribeirão Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suspected of having dengue disease

  • Patients were included in the study if they presented with fever and at least two other symptoms, such as:

    • headache
    • pain behind the eyes
    • muscle and bone or joint pains
    • nausea
    • vomiting
    • rash associated to dengue for less than 72 hours

Exclusion Criteria:

  • Pregnant
  • Younger than 18-years old
  • Either cardiac or neurologic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: Chloroquine
Chloroquine bid for three days
Placebo Comparator: 1
Drug: Placebo
Placebo bid for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of the disease
Time Frame: one week
one week

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensity and days of fever and symptoms
Time Frame: one week
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Benedito AL Fonseca, PhD, São Paulo University Medical School at Ribeirão Preto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

May 1, 2008

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

February 24, 2009

Last Update Submitted That Met QC Criteria

February 23, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BALF-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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