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Completed

NCT Number: NCT02446782

Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy

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.

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Key information

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PGIMER

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cefazolin

Drug

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 names: Clindamycin

Saline

Other

100 mL normal saline 15-30 minutes before the start of the procedure

Primary outcomes

  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 outcomes

  1. Safety as assessed by adverse effects

    Time frame: 7 days

    Adverse effects arising as a result of the antibiotic administered

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study 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

Acronym: APT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 18, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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