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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02446782

Acronym

APT

Enrollment

100

Registered

2015-05-18

Start date

2015-01-31

Completion date

2016-06-30

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empyema, Pleural Effusion, Pleurisy

Keywords

thoracoscopy, pleuroscopy, antibiotic prophylaxis, pleural effusion

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.

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.

Interventions

DRUGCefazolin

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.

OTHERsaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy as assessed by occurrence of wound infection or pleural space infection	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

Measure	Time frame	Description
Safety as assessed by adverse effects	7 days	Adverse effects arising as a result of the antibiotic administered

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026