Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03477292 |
| Other study ID # |
IEC/82 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Postgraduate Institute of Medical Education and Research |
| Contact |
Inderpaul S Sehgal, MD,DM |
| Phone |
911275 |
| Email |
inderpgi[@]outlook.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
