ClinicalTrials.gg
Status unknownNCT03413293Updated May 18, 2018

Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients

An observational study in Nosocomial Infection, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study summary

Hospital acquired chest Infections are common complications in hospitalized cirrhotic patients. Infectious complications are the most common cause of mortality in cirrhotic patients with bronchopneumonia early antibiotic treatment at the base of culture and sensitivity is an optimal therapeutic approach in cirrhotics with nosocomial pneumonia Intensive care unit acquired pneumonia is the leading infection in critically ill patients and a major cause of morbidity and mortality despite recent major advances in antimicrobial therapy, supportive care, and the use of a broad range of preventive measures

Read the detailed description

Aim of the work

  1. To estimate the frequency and risk factors of nosocomial chest infections in cirrhotic patients .
  2. To determine the causative pathogens of nosocomial chest infections in patients with cirrhosis including fungal infections in order to establish our local empirical antimicrobial protocol.
  3. To define the impact of nosocomial chest infections on survival of our patients.
  4. To develop an effective and continuous surveillance program and infection control measures to reduce the burden of these infections as well as morbidity , mortality , hospital stay ,hospital cost and to achieve quality of care .
  5. To motivate pharmaceutical companies to create a new umbrella coverage of antimicrobials through the ongoing knowledge of the changes in microbial resistance pattern inside hospitals
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Conditions studied

  • Nosocomial Infection

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03

In context

Cross Infection

285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.

This study's planned enrollment of 20 is below the median of 351 across 115 observational studies indexed under Cross Infection.

Browse Cross Infection studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patient were known to have liver cirrhois and admitted at hospital secondary to any cause

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All cirrhotic patients , decompensated , child pug score B or C ,may have Hepatocellular carcinoma , other comorbidities may present as (Diabetius mellitus , Hypertension , Heart disease and renal impairment ) , both sex and with clinical suspicion of chest infections acquired after 48 hours of admission

Exclusion criteria

Exclusion Criteria:

  • Patients have any chronic chest disease
  • Patients have severe (neutropenia after chemotherapy or hematopoietic transplant, drug-induced immunosuppression in solid-organ transplant or cytotoxic therapy, and -related disorders.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Nosocomial infected cirrhotic patients

    Diagnostic Test: Diagnosis of bacterial infections

Interventions

  • Diagnostic testDiagnosis of bacterial infections

    Cultures

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What researchers measure

Primary outcomes

  1. Frequency of nosocomial infection in patients with liver cirrhosis

    nosocomial infection is one of predictors of bad outcome in liver cirrhosis

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Di Pasquale M, Esperatti M, Crisafulli E, Ferrer M, Bassi GL, Rinaudo M, Escorsell A, Fernandez J, Mas A, Blasi F, Torres A. Impact of chronic liver disease in intensive care unit acquired pneumonia: a prospective study. Intensive Care Med. 2013 Oct;39(10):1776-84. doi: 10.1007/s00134-013-3025-6. Epub 2013 Aug 2. PubMed 23907496 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2018; primary completion for May 2019, 11 months later.

Of 56 non-industry observational studies under Cross Infection, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's planned 11 months is below that.

Counting every sponsor, half of 56 studies reached it within 28 months; a quarter within 17 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2018
First posted
Jan 29, 2018
StartEst.
Jun 2018
Primary completionEst.
May 2019
CompletionEst.
Aug 2019
Last update
May 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03413293
Lead sponsor
Assiut University
Responsible party
NZBakhiet (resident doctor, Assiut University) — Principal investigator
First posted
Jan 29, 2018
Start date
Jun 2018 (estimated)
Primary completion
May 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
May 18, 2018

Study contacts

Nariman zaghluol bakhiet, postgraduate
Contact
narimandoctor@yahoo.com
01005546130

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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