FeverPhase 4NCT01089218
The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
A Phase 4 study testing oral amoxicillin/clavulanate 1g (875/125mg) in people with Fever and Pneumonia, run by Seoul National University Hospital.
Trial summary
Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- oral amoxicillin/clavulanate 1g (875/125mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Feb 2010
- Phase
- Phase 4
- 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
- adult patients (aged 18 years or older) who underwent FB
Who cannot join
- concurrent treatment with antibiotics or systemic corticosteroid
About this study
Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia.
Read the detailed description
For the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.
- Being tested
- oral amoxicillin/clavulanate 1g (875/125mg), control
- Keywords
- bronchoscopy, post-bronchoscopy fever, pneumonia, cytokines, amoxicillin/clavulanate, prophylaxis
- Medical subject headings
- Fever, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral amoxicillin/clavulanate 1g (875/125mg)Drug
Also called prophylaxis group
oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB
controlDrug
no intervention with the same procedure of FB
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | control without intervention Receives: Drug: control |
| Amoxicillin/clavulanate | Active comparator | Not described Receives: Drug: oral amoxicillin/clavulanate 1g (875/125mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of fever
time frame for body temperature 24hr before and after bronchoscopy every 4hrs
Measured: 24 hr after bronchoscopy
Secondary outcomes (1)
change of serum cytokines level
Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy
Measured: before bronchoscopy and 24hr after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Deog Kyeom Kim, MD., Study director, Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 39 Boramae-Gil, Dongjak-Gu, Seoul, Republic of Korea 156-707.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089218
- Sponsor's protocol ID
- postFB fever
- Status last verified
- Jul 2011
- First submitted
- 14 Mar 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park JS, Lee CH, Yim JJ, Yang SC, Yoo CG, Chung HS, Kim YW, Han SK, Shim YS, Kim DK. Impact of antibiotic prophylaxis on postbronchoscopy fever: a randomised controlled study. Int J Tuberc Lung Dis. 2011 Apr;15(4):528-35. doi: 10.5588/ijtld.10.0386.
PubMed 21396214
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
- ClinicalTrials.gov ID
- NCT01089218
- Acronym / sponsor ID
- postFB fever
- Keywords
- bronchoscopy, post-bronchoscopy fever, pneumonia, cytokines, amoxicillin/clavulanate, prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Mar 2010 (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.
Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia.
Detailed description
For the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | Drug: controlcontrol without intervention |
| Amoxicillin/clavulanate | Active comparator | Drug: oral amoxicillin/clavulanate 1g (875/125mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (aged 18 years or older) who underwent FB
Key exclusion criteria (1 listed)
- concurrent treatment with antibiotics or systemic corticosteroid
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 |
|---|---|---|
| oral amoxicillin/clavulanate 1g (875/125mg)Also: prophylaxis grouporal amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB | Drug | Amoxicillin/clavulanate |
| controlno intervention with the same procedure of FB | Drug | control |
Primary outcome
The incidence of fever
Time frame: 24 hr after bronchoscopy
time frame for body temperature 24hr before and after bronchoscopy every 4hrs
1 secondary outcome
change of serum cytokines level
Time frame: before bronchoscopy and 24hr after bronchoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
- Derived from this study: PubMed 21396214Park JS, Lee CH, Yim JJ, Yang SC, Yoo CG, Chung HS, Kim YW, Han SK, Shim YS, Kim DK. Impact of antibiotic prophylaxis on postbronchoscopy fever: a randomised controlled study. Int J Tuberc Lung Dis. 2011 Apr;15(4):528-35. doi: 10.5588/ijtld.10.0386.
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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.
Deog Kyeom Kim, MD. study director
Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 39 Boramae-Gil, Dongjak-Gu, Seoul, Republic of Korea 156-707.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral amoxicillin/clavulanate 1g (875/125mg) in people with Fever and Pneumonia, run by Seoul National University Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of fever (time frame: 24 hr after bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089218, which also lists 1 linked publication.
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 21 Jul 2011.