Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis

  • STATUS
    Recruiting
  • End date
    Oct 16, 2024
  • participants needed
    432
  • sponsor
    University College, London
Updated on 16 October 2021

Summary

A multicentre, interventional, double-blind, placebo-controlled, parallel-arm, phase 3, randomised controlled trial to evaluate the use of co-trimoxazole as primary prophylaxis for spontaneous bacterial peritonitis to improve overall survival

Description

See above

Details
Condition Spontaneous Bacterial Peritonitis
Treatment Placebo Oral Tablet, Co-Trimoxazole 960Mg Dispersible Tablet
Clinical Study IdentifierNCT04395365
SponsorUniversity College, London
Last Modified on16 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with Child-Pugh Class B or C cirrhosis and presence of ascites requiring any diuretic treatment or at least 1 or more paracentesis within 3 months prior to enrolment
Patient at least 18 years of age
Documented informed consent to participate

Exclusion Criteria

Patients with current or previous Spontaneous Bacterial Peritonitis (defined as ascitic polymorphonuclear (PMN) cell count >250/mm3 with either positive or negative ascitic fluid culture without evident intra-abdominal surgically treatable source of infection. A white cell count >500 cell/mm2 or positive microbial culture may be considered as evidence of previous SBP if the site PI considers this was in the context of a likely clinical diagnosis of SBP)
Patients receiving palliative care with an expected life expectancy of <8 weeks
Allergic to co-trimoxazole, trimethoprim or sulphonamides
Pregnant or lactating mothers
Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
Patients with serum potassium (>5.5 mmol/L) related to pre-existing kidney disease which cannot be reduced
Patients receiving antibiotic prophylaxis (except for rifaximin)
Patients with long-term ascites drains
Women of child-bearing potential and males with a partner of child-bearing potential without effective contraception for the duration of trial treatment
Patients with pathological blood count changes
Patients with haemoglobin (Hb) <70g/L
Severe thrombocytopenia with a platelet count <30 x109 /L
Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter
Patients with severe renal impairment, with eGFR <15 ml/min
Patients with skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms
Patients with congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Kln and Hb Zrich
Patients with acute porphyria
Any clinical condition which the investigator considers would make the patient unsuitable for the trial
It is common for these investigations to change in patients with cirrhosis and long-term ascitic drains may be removed. Patients can be re-screened for eligibility if this occurs
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note