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

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ClinicalTrials.gov Identifier: NCT03477292
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Inderpaul singh, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Drug: Duration of antibiotic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Compare 7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia Due to Drug Resistant Acinetobacter Baumanii
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Long duration of antibiotics
14 days of Colistin
Drug: Duration of antibiotic
Duration of antibiotic for treatment of VAP
Other Name: Colisitin

Active Comparator: Short duration of antibiotics
7 days of Colistin
Drug: Duration of antibiotic
Duration of antibiotic for treatment of VAP
Other Name: Colisitin




Primary Outcome Measures :
  1. Relapses of VAP [ Time Frame: 28 days ]
    defined as repetitive clinically and microbiologically documented VAP due to the same pathogen


Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: 28 days ]
    (non-invasive and invasive)

  2. ICU and hospital length of stay [ Time Frame: 90 days ]
    Days spent in ICU and hospital

  3. 28-day mortality [ Time Frame: 28 days ]
    ICU or hospital mortality

  4. Antibiotic free days [ Time Frame: 28 days ]
    Number of days spent without antibiotics



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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): NCT03477292


Contacts
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Contact: Inderpaul S Sehgal, MD,DM 911275 ext 6823 inderpgi@outlook.com
Contact: Ritesh Agarwal, MD,DM 911275 ext 6825 agarwal.ritesh@outlook.in

Locations
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India
Respiratory ICU, Department of Pulmonary Medicine, PGIMER Recruiting
Chandigarh, India, 160012
Contact: Inderpaul S Sehgal, MD,DM    911275 ext 6823    inderpgi@outlook.com   
Contact: Ritesh Agarwal, MD,DM    911275 ext 6825    agarwal.ritesh@outlook.in   
Respiratory ICU, Post Graduate Institue of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Inderpaul S Sehgal, MD,DM    9111722756823    inderpgi@outlook.com   
Contact: Ritesh Agarwal, MD,DM    9111722756825    agarwal.ritesh@outlook.in   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Inderpaul singh, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03477292     History of Changes
Other Study ID Numbers: IEC/82
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: anonymized individual patient information and clinical details will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection