DenguePhase 1/2NCT00849602
The Effect of Chloroquine in the Treatment of Patients With Dengue
A Phase 1/2 study testing Chloroquine in people with Dengue, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dengue
- What is being tested?
- Chloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Jun 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Younger than 18-years old
- Either cardiac or neurologic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
São Paulo University Medical School at Ribeirão Preto
Ribeirão Preto, São Paulo, 14048.900
About this study
The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.
- Conditions
- Dengue
- Being tested
- Placebo, Chloroquine
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo bid for three days
ChloroquineDrug
Chloroquine bid for three days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the disease
Measured: one week
Secondary outcomes (1)
Intensity and days of fever and symptoms
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2008 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Benedito AL Fonseca, PhD, Principal investigator, São Paulo University Medical School at Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849602
- Sponsor's protocol ID
- BALF-01
- Status last verified
- Feb 2009
- First submitted
- 23 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chloroquine in the Treatment of Patients With Dengue
- ClinicalTrials.gov ID
- NCT00849602
- Acronym / sponsor ID
- BALF-01
- Conditions
- Dengue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2008
- Primary completion
- May 2008 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: Chloroquine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- Pregnant
- Younger than 18-years old
- Either cardiac or neurologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo bid for three days | Drug | 1 |
| ChloroquineChloroquine bid for three days | Drug | 2 |
Primary outcome
Duration of the disease
Time frame: one week
1 secondary outcome
Intensity and days of fever and symptoms
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benedito AL Fonseca, PhD principal investigator
São Paulo University Medical School at Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chloroquine in people with Dengue, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the disease (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2009.