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7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia

Primary Purpose

Ventilator Associated Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Duration of antibiotic
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Associated Pneumonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(a) Patients who develop ventilator associated pneumonia due to drug-resistant Acinetobacter baumanii; (b) age group of 18 to 75 years

Exclusion Criteria:

(a) VAP due to other organisms; (b) pregnancy; (c) endotracheal or tracheostomy tube aspirate demonstrating growth of drug sensitive Acinetobacter baumanii or an organism other than Acinetobacter baumanii; and, (c) failure to provide informed consent.

Sites / Locations

  • Respiratory ICU, Department of Pulmonary Medicine, PGIMERRecruiting
  • Respiratory ICU, Post Graduate Institue of Medical Education and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long duration of antibiotics

Short duration of antibiotics

Arm Description

14 days of Colistin

7 days of Colistin

Outcomes

Primary Outcome Measures

Relapses of VAP
defined as repetitive clinically and microbiologically documented VAP due to the same pathogen

Secondary Outcome Measures

Duration of mechanical ventilation
(non-invasive and invasive)
ICU and hospital length of stay
Days spent in ICU and hospital
28-day mortality
ICU or hospital mortality
Antibiotic free days
Number of days spent without antibiotics

Full Information

First Posted
March 20, 2018
Last Updated
April 11, 2023
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03477292
Brief Title
7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia
Official Title
A Study to Compare 7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia Due to Drug Resistant Acinetobacter Baumanii
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.
Detailed Description
Ventilator-associated pneumonia (VAP) is one of the major causes of morbidity and mortality in the ICU, accounting for 25% of the total infections occurring in this setting and 50% of all antibiotic prescriptions in patients who are mechanically ventilated.1,2 The incidence of VAP depends not only on the type of the institution, the preventive measures and therapeutic approaches that are used, but also on the type of surveillance systems by which incidence is estimated. There are reports of incidence across different settings varying from 1.4 up to 42.8 episodes of VAP/1,000 ventilation-days.2 Patients with VAP have significantly longer ICU and hospital lengths of stay compared with similar patients without VAP.3,4 Consequently, the economic burden of VAP is considerable, leading to significant draining of resources. Even after adjusting for underlying severity of illness, the attributable cost of VAP amounts to several thousands of US dollars per patient.5 There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found.9 There was an increase in the antibiotic free days in the short course antibiotic arm. There was no difference in the number of relapses of VAP with either modality of treatment.9 In another analysis of six studies with 1088 subjects, there was a higher occurrence of relapses of VAP due to non-lactose fermenting gram negative organism.10 However, there was no difference in the mortality rates.10 The problem with both these meta-analyses was that they did not provide information regarding the outcomes of VAP due to Acinetobacter baumanii.9,10 Also, the short duration strategy included studies that randomized patients to seven to eight days and ten-to fifteen days in the long duration strategy. None of the previous studies has provided information about outcomes of VAP due to Acinetobacter baumanii. In our observation, most of the episodes of VAP in our ICU are due to drug resistant Acinetobacter baumanii. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long duration of antibiotics
Arm Type
Experimental
Arm Description
14 days of Colistin
Arm Title
Short duration of antibiotics
Arm Type
Active Comparator
Arm Description
7 days of Colistin
Intervention Type
Drug
Intervention Name(s)
Duration of antibiotic
Other Intervention Name(s)
Colisitin
Intervention Description
Duration of antibiotic for treatment of VAP
Primary Outcome Measure Information:
Title
Relapses of VAP
Description
defined as repetitive clinically and microbiologically documented VAP due to the same pathogen
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
(non-invasive and invasive)
Time Frame
28 days
Title
ICU and hospital length of stay
Description
Days spent in ICU and hospital
Time Frame
90 days
Title
28-day mortality
Description
ICU or hospital mortality
Time Frame
28 days
Title
Antibiotic free days
Description
Number of days spent without antibiotics
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (a) Patients who develop ventilator associated pneumonia due to drug-resistant Acinetobacter baumanii; (b) age group of 18 to 75 years Exclusion Criteria: (a) VAP due to other organisms; (b) pregnancy; (c) endotracheal or tracheostomy tube aspirate demonstrating growth of drug sensitive Acinetobacter baumanii or an organism other than Acinetobacter baumanii; and, (c) failure to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inderpaul S Sehgal, MD,DM
Phone
911275
Ext
6823
Email
inderpgi@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ritesh Agarwal, MD,DM
Phone
911275
Ext
6825
Email
agarwal.ritesh@outlook.in
Facility Information:
Facility Name
Respiratory ICU, Department of Pulmonary Medicine, PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inderpaul S Sehgal, MD,DM
Phone
911275
Ext
6823
Email
inderpgi@outlook.com
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD,DM
Phone
911275
Ext
6825
Email
agarwal.ritesh@outlook.in
Facility Name
Respiratory ICU, Post Graduate Institue of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inderpaul S Sehgal, MD,DM
Phone
9111722756823
Email
inderpgi@outlook.com
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD,DM
Phone
9111722756825
Email
agarwal.ritesh@outlook.in

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
anonymized individual patient information and clinical details will be shared

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7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia

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