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Trial record 10 of 25 for:    "Pleural Disease" | "Anti-Bacterial Agents"

Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy (APT)

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ClinicalTrials.gov Identifier: NCT02446782
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sahajal Dhooria, Postgraduate Institute of Medical Education and Research

Brief Summary:
This is a prospective study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections in patients undergoing medical thoracoscopy.

Condition or disease Intervention/treatment Phase
Pleural Effusion Pleurisy Empyema Drug: Cefazolin Other: saline Phase 4

Detailed Description:

This is a prospective randomized study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections during medical thoracoscopy.

Consecutive patients who are planned to undergo a medical thoracoscopy (rigid or semirigid) will be enrolled in the study if they satisfy the inclusion and exclusion criteria. One hundred patients will be randomized in 1:1 ratio to receive either of the following: (a) A single dose of intravenous cefazolin 2 gms dissolved in 100 mL of normal saline administered over 10 minutes, between 15 and 30 minutes before the incision, OR (b) 100 mL normal saline administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. Thoracoscopy will be performed in the bronchoscopy suite on a spontaneously breathing subject (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Efficacy and Safety of a Single Dose of an Injectable Antibiotic for the Prophylaxis of Surgical Site and Pleural Space Infection After Medical Thoracoscopy
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Cefazolin
A single dose of intravenous cefazolin 2 gms will be administered over 10 minutes, dissolved in 100 mL of normal saline between 15 and 30 minutes before the incision. This will be preceded by an intradermal test dose to check for hypersensitivity to the drug. If hypersensitivity is present, the patient will be administered a single dose of intravenous Clindamycin 900 mg.
Drug: Cefazolin
Cefazolin 2 gm administered in 100 mL normal saline (after skin sensitivity testing) 15-30 minutes before the start of the procedure. Clindamycin 900 mg to be administered if sensitivity detected to cefazolin.
Other Name: Clindamycin

Placebo Comparator: saline
100 mL normal saline will be administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. An intradermal test dose with normal saline will be administered to this group.
Other: saline
100 mL normal saline 15-30 minutes before the start of the procedure




Primary Outcome Measures :
  1. Efficacy as assessed by occurrence of wound infection or pleural space infection [ Time Frame: 2 months ]
    (a) Occurrence of wound infection as indicated by development of a purulent discharge from the surgical site or (b) pleural space infection as indicated by development of purulence, fall in sugar levels or gram's stain or culture positivity in the pleural fluid drained by the chest tube on the side of the procedure.


Secondary Outcome Measures :
  1. Safety as assessed by adverse effects [ Time Frame: 7 days ]
    Adverse effects arising as a result of the antibiotic administered



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥12 years
  2. Medical thoracoscopy being performed for a pleural effusion for any of the three indications: diagnosis, pleurodesis, or adhesiolysis

Exclusion Criteria:

  1. Age ≥80 years
  2. Pao2/FIO2< 300;
  3. Hemodynamic instability
  4. Myocardial infarction or unstable angina in the last 6 wk
  5. Lack of pleural space due to adhesions
  6. Uncorrected coagulopathy
  7. Failure to provide informed consent
  8. Patients already taking any antibiotic due to any reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446782


Locations
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India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Sahajal Dhooria, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02446782     History of Changes
Other Study ID Numbers: NK/1816/Res/2440
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Sahajal Dhooria, Postgraduate Institute of Medical Education and Research:
thoracoscopy
pleuroscopy
antibiotic prophylaxis
pleural effusion
Additional relevant MeSH terms:
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Pleural Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Empyema
Pleural Effusion
Pleurisy
Respiratory Tract Diseases
Suppuration
Infection
Inflammation
Pathologic Processes
Respiratory Tract Infections
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cefazolin
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action