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The Effect of Chloroquine in the Treatment of Patients With Dengue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00849602
First received: February 23, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Chloroquine in the Treatment of Patients With Dengue

Resource links provided by NLM:

MedlinePlus related topics: Dengue
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Duration of the disease [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intensity and days of fever and symptoms [ Time Frame: one week ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 23, 2009
Last Updated: February 23, 2009
Health Authority: Brazil: Ethics Committee

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
Therapeutic Uses
 Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013