Health Trials

Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

ConditionClostridioides Difficile Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of 3 or more unformed stools (Bristol stool scale 6 or 7) in ≤ 24 hours for 2 consecutive calendar days, (Note: Diarrhea is not required to be present on the day of IMP administration) and

Positive local C. difficile toxin test (eg, immune assay or CCNA) on a stool sample collected during this episode, as part of routine clinical care (Note: Toxin testing, where not part of routine clinical care, may be conducted as a pre- screening activity; if this occurs, participant consent is required), and

Planned initiation or receipt of antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode,

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD5148

    Drug

    Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.

  • Placebo

    Other intervention

    Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: AZD5148: dose AExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

First occurrence of recurrence of C difficile infection

Recurrence of C difficile infection (rCDI) occurring after initial clinical cure (ICC) of the qualifying C difficile infection (CDI). CDI is defined as a history of diarrhea (\>=3 unformed stools, ie, type 6 or 7 stool on Bristol Stool Scale in \<=24 hours for 2 consecutive calendar days) accompanied by a positive stool test for C difficile toxin.

Time frame
Day 1 through day 91

Secondary outcomes

1

Sustained clinical cure

Sustained clinical cure is defined as achieving ICC of the qualifying CDI and not having an rCDI event through Day 91. ICC is defined as clinical cure for the qualifying CDI episode with a duration of a minimum of 10 days and a maximum of 28 days of antibacterial drug therapy for CDI.

Time frame
Day 91
2

Duration of recurrent C difficile infection

Duration of the first occurrence of confirmed rCDI is calculated from the first day of diarrhea meeting the clinical symptom criteria until the date of clinical cure. Clinical cure is defined as \<=2 unformed stools (ie, type 6 or 7 stool on Bristol Stool Scale) in 24 hours for 2 consecutive calendar days after the end of antibacterial drug treatment for the CDI episode.

Time frame
Day 1 through Day 91
3

First occurrence of severe recurrent C difficile infection

Severe rCDI is defined as an rCDI event characterized by either: peripheral blood leukocytosis with leukocyte count \>15,000 cells/uL or serum creatinine level \>1.5 mg/dL.

Time frame
Day 1 through Day 91
4

First occurrence of fulminant recurrent C difficile infection

Fulminant rCDI is defined as a severe rCDI event with hypotension or shock, toxic megacolon, or ileus.

Time frame
Day 1 through Day 91

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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