Escherichia coli strain Nissle 1917 - Suspension for treatment of patients with Clostridium difficile associated diarrhoea

Phase 1

• Conditions: Clostridium difficile associated diarrhoea (CDAD); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-004531-36-DE
• Lead Sponsor: Ardeypharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-23
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

oSigned informed consent form by the patient
oC. difficile associated diarrhoea (illnesses of mild to moderate severity)
oAge = 18 years with life expectancy of 3 months or more
oPositive detection of C. difficile protein GDH and toxin A and / or B and diarrhoea (definition: = 3 liquid or watery stools per day or = 8 in 48 h)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

oNon-fulfilment of at least one inclusion criterion
oParticipation in an interventional clinical trial according to the German medicines act (AMG) within the last 30 days or simultaneously
oExpectable lack of cooperation/compliance
oWomen of childbearing potential without conceptual protection
oPregnancy and breast feeding period
oAbuse of alcohol (daily intake of 20 g of pure alcohol in women and 30 g of pure alcohol in men), medications or drugs
oLimited legal capacity
oHousing in an institution as a result of official or court orders
oDependency of a person on sponsor, trial site or investigator
oIncompatibility with study medication
oNecessity of intake of other antidiarrhoeals, especially antimotility agents
oOther reasons that, in the opinion of the examiner, speak against inclusion of the patient to the trial
oThe presence of more than 2 of the following predictors of increased risk of a severe CDAD progression:
? Fever > 38.5 °C
? Leucocytosis > 15 × 10^9/L
? Left shift > 20% rod meaty granulocytes
? Hypoalbuminemia < 30 g/L
? Creatinine increase > 50% of initial value
? Lactate boost = 5mmol/l
? Age > 75 years
? Significant morbidity (e.g. renal failure, immune suppression, etc.)

oSevere form of the CDAD/ C. difficile infection (CDI):
Severe CDAD/CDI is defined as an episode of CDAD/CDI with (one or more specific signs and symptoms of) severe colitis or a complicated course of disease, with significant systemic toxin effects and shock, resulting in need for intensive care unit (ICU) admission, colectomy or death
oEnterocolitis that is not associated with C. difficile infection, such as active Crohn's disease*, active ulcerative colitis*, colitis caused by radiation or other pathogen-induced colitis
oPositive TPER-Test (test will only be performed on patients with community acquired CDAD)
oOther serious comorbidities, which, in the opinion of the investigator, call into question the protocol-compliant implementation of the study. This applies in particular to comorbidities, which could worsen if there is an aggravation of the CDAD.
oNon-deductibility of a current antibiotic treatment of a disease other than the CDAD.
oIntake of more than three 400 mg-doses of metronidazole (daily dose) or longer than 24 hours of metronidazole therapy to treat the acute CDAD episode before enrolment into the study.
oIntake of more than four 125 mg-doses of vancomycin (daily dose) or longer than 24 hours of vancomycin therapy to treat the acute CDAD episode before enrolment into the study.
oTaking more than three doses or longer than 24 hours of a probiotic drug to treat the acute CDAD episode before enrolment into the study.

* Patients in remission are not excluded from the study!

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified