The Effect of Chloroquine in the Treatment of Patients With Dengue

This study is ongoing, but not recruiting participants.

First Received: February 23, 2009 No Changes Posted

Sponsors and Collaborators:	University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00849602

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Chloroquine in the Treatment of Patients With Dengue

Resource links provided by NLM:

MedlinePlus related topics: Dengue Fever

Drug Information available for: Chloroquine diphosphate Chloroquine Chloroquine hydrochloride

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
1: Placebo Comparator	Drug: Placebo Placebo bid for three days
2: Active Comparator	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, SP
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:	São Paulo University Medical School at Ribeirão Preto ( Benedito Antonio Lopes da Fonseca )
Study ID Numbers:	BALF-01
Study First Received:	February 23, 2009
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00849602 History of Changes
Health Authority:	Brazil: Ethics Committee

Study placed in the following topic categories:

Anti-Inflammatory Agents
Anti-Infective Agents
Dengue Fever
Chloroquine
Anthelmintics
Dengue Hemorrhagic Fever
Fever
Virus Diseases
Antimalarials
Hemorrhagic Fevers, Viral

Analgesics, Non-Narcotic
Dengue
Chloroquine diphosphate
Viral Hemorrhagic Fever
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Arbovirus Infections
Hemorrhagic Fever
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Flaviviridae Infections
Physiological Effects of Drugs
Antimalarials
Antiparasitic Agents
Hemorrhagic Fevers, Viral
Dengue
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Amebicides
Analgesics
Antinematodal Agents

RNA Virus Infections
Flavivirus Infections
Filaricides
Chloroquine
Anthelmintics
Pharmacologic Actions
Dengue Hemorrhagic Fever
Virus Diseases
Analgesics, Non-Narcotic
Chloroquine diphosphate
Arbovirus Infections
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 30, 2009