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The Effect of Chloroquine in the Treatment of Patients With Dengue

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00849602
First Posted: February 24, 2009
Last Update Posted: February 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
  Purpose
The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.

Condition Intervention Phase
Dengue Drug: Placebo Drug: Chloroquine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Chloroquine in the Treatment of Patients With Dengue

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Duration of the disease [ Time Frame: one week ]

Secondary Outcome Measures:
  • Intensity and days of fever and symptoms [ Time Frame: one week ]

Estimated Enrollment: 132
Study Start Date: February 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo bid for three days
Active Comparator: 2 Drug: Chloroquine
Chloroquine bid for three days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849602


Locations
Brazil
São Paulo University Medical School at Ribeirão Preto
Ribeirão Preto, SP, Brazil, 14048.900
Sponsors and Collaborators
University of Sao Paulo
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
  More Information

Responsible Party: Benedito Antonio Lopes da Fonseca, São Paulo University Medical School at Ribeirão Preto
ClinicalTrials.gov Identifier: NCT00849602     History of Changes
Other Study ID Numbers: BALF-01
First Submitted: February 23, 2009
First Posted: February 24, 2009
Last Update Posted: February 24, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics