A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.

NCT04208763 | Unknown

• 1 other identifier: ILBS-SBP-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Study population: A total of 90 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences with SBP with septic shock will be included. Study design: Randomized controlled trial Study period: August 2019 to December 2021. Sample size: Assuming that the response rate is 90% with GM-CSF and 60% without GM-CSF after day 5. With alpha 5 and power 80,we need to enroll 76 cases (38 cases with each). Further assuming 20 % drop-out due to various reasons, it was decided to enroll 90 cases randomly allocated into two groups (i.e., 45 in each) by block randomization method by taking block size as 6. So for the present study, it was decided to enroll 90 cases in all. Group A will be given Imipenem and Tigecycline. Patients with recent hospitalisation will be given Colistin in addition. Group B will be given: To another group we will give Imipenem and Tigecycline and GMCSF.Patients with recent hospitalisation will be given Colistin in addition. The dose of antibiotic will be given at dosage Inj Imipenem 1gm i.v. TDS Inj Tigecycline 100mg stat f/b 50mg i.v. OD Inj GM-CSF 500mcg s.c. OD Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD Monitoring and assessment At the baseline, all patients will undergo investigational evaluation as described Daily monitoring of following parameters:

• Haemoglobin,
• Total peripheral leucocyte counts,
• Platelet counts,
• Renal function tests
• Liver function tests and
• Chest X rays will be undertaken
• Ascitic fluid analysis will be done on day 0, day 2 and day 5 Stopping rule:If the patient develops a TLC of more than 50,000, the dose of the GM CSF will be reduced to half and the treatment continued. If, even after the reduction, the TLC rises to more than 50,000, then the treatment will be stopped and the patient excluded. Expected outcome of the project: Addition of GM-CSF to standard antibiotic regimen helps resolve SBP and improves outcome in decompensated liver cirrhotic patients.

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• Resolution of Spontaneous Bacterial peritonitis in both groups

  Response is defined by resolution of SBP in terms of total counts \< 500,Neutrophil\<250

  Day 5

Secondary Outcomes (11)

• Reversal of shock in both groups

  Day 2

• Survival in both groups

  Day 7

• Survival in both groups

  Day 28

• Change in ascitic fluid metabolites Nitric Oxide in both groups

  Day 28

• Change in ascitic fluid macrophage population in both groups

  Day 28

Study Arms (2)

Imipenem+Tigecycline+GM-CSF

EXPERIMENTAL

Drug: Imipenem; Drug: Tigecycline; Drug: GMCSF; Drug: Colistin

Imipenem+Tigecycline

ACTIVE COMPARATOR

Drug: Imipenem; Drug: Tigecycline; Drug: Colistin

Interventions

Imipenem DRUG

Inj Imipenem 1gm i.v. TDS

Imipenem+Tigecycline; Imipenem+Tigecycline+GM-CSF

Tigecycline DRUG

Inj Tigecycline 100mg stat f/b 50mg i.v. OD

Imipenem+Tigecycline; Imipenem+Tigecycline+GM-CSF

GMCSF DRUG

Inj GM-CSF 500mcg s.c. OD

Imipenem+Tigecycline+GM-CSF

Colistin DRUG

Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD

Imipenem+Tigecycline; Imipenem+Tigecycline+GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spontaneous Bacterial Peritonitis (SBP) with shock in a cirrhotic
• Hospital acquired SBP with shock
• Difficult to treat SBP

You may not qualify if:

• Refractory Shock
• Cardiac comorbidities (known Coronary Artery Disease)
• Chronic Kidney Disease on Maintenance Hemodialysis
• \< 18 years.
• Advanced Hepatocellular Carcinoma
• Post liver transplant
• HIV + ve, Immunosuppressive therapy

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

Imipenem; Tigecycline; Colistin

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Central Study Contacts

Dr Abhijeet Ranjan, MD

CONTACT

01146300000; drkmrabhijeet@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 23, 2019
• Study Start: December 20, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

IN (1)