HemopneumothoraxPhase 2/3NCT01127880
Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax
A Phase 2/3 study testing Ancef or Clindamycin in people with Hemopneumothorax and Pneumothorax, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemopneumothorax, Pneumothorax
- What is being tested?
- Ancef or Clindamycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2009
- Phase
- Phase 2/3
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years of age.
- Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
- Traumatic pneumothorax, hemothorax or hemopneumothorax
Who cannot join
- Pregnancy
- Open fracture
- Immunocompromised
- Require antibiotics for treatment of other injuries
- Chest tube placement greater than 72hrs after admission
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015
About this study
Official title: The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study
The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
Read the detailed description
In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.
- Conditions
- Hemopneumothorax, Pneumothorax
- Being tested
- Ancef or Clindamycin, Placebo
- Keywords
- Traumatic Hemopneumothorax, Thoracotomy, Antibiotics
- Medical subject headings
- Hemopneumothorax, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ancef or ClindamycinDrug
1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic
PlaceboDrug
.9% Normal Saline as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Ancef 1 gm or Clindamycin 300 mg | Active comparator | Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists Receives: Drug: Ancef or Clindamycin |
| Placebo | Placebo comparator | Group B will receive .9% Normal Saline as a placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of prophylactic antibiotics in reduction of empyema
The primary objective of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
Measured: 30 days
Secondary outcomes (1)
Incidence of Pneumonia and/or development of resistant microorganisms
Secondary objectives include:
Incidence of pneumonia Incidence of development of resistant microorganisms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJul 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemopneumothoraxStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Nathaniel McQuay, MD, Principal investigator, St. Luke's Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127880
- Sponsor's protocol ID
- SLHN 2005-34
- Status last verified
- Feb 2009
- First submitted
- 19 May 2010
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study
- ClinicalTrials.gov ID
- NCT01127880
- Acronym / sponsor ID
- SLHN 2005-34
- Conditions
- Hemopneumothorax, Pneumothorax
- Keywords
- Traumatic Hemopneumothorax, Thoracotomy, Antibiotics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 May 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.
The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
Detailed description
In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ancef 1 gm or Clindamycin 300 mg | Active comparator | Drug: Ancef or ClindamycinGroup A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists |
| Placebo | Placebo comparator | Drug: PlaceboGroup B will receive .9% Normal Saline as a placebo. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 16 years of age.
- Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
- Traumatic pneumothorax, hemothorax or hemopneumothorax
Key exclusion criteria (5 listed)
- Pregnancy
- Open fracture
- Immunocompromised
- Require antibiotics for treatment of other injuries
- Chest tube placement greater than 72hrs after admission
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 |
|---|---|---|
| Ancef or Clindamycin1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic | Drug | Ancef 1 gm or Clindamycin 300 mg |
| Placebo.9% Normal Saline as a placebo | Drug | Placebo |
Primary outcome
efficacy of prophylactic antibiotics in reduction of empyema
Time frame: 30 days
The primary objective of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
1 secondary outcome
Incidence of Pneumonia and/or development of resistant microorganisms
Time frame: 30 days
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 May 2010.
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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.
Nathaniel McQuay, MD principal investigator
St. Luke's Hospital and Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ancef or Clindamycin in people with Hemopneumothorax and Pneumothorax, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
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 3 inclusion and 5 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 May 2010. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
efficacy of prophylactic antibiotics in reduction of empyema (time frame: 30 days). 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 21 May 2010.