Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

Actelion84 enrolled

Overview

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Clostridium Difficile Infection

Interventions

CadazolidDRUG

Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration

VancomycinDRUG

Vancomycin, provided as capsules (125 mg) for oral administration

Placebo-matching cadazolidDRUG

Placebo of cadazolid powder for oral suspension

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Male or female * At least 18 years of age * With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence. Key Exclusion Criteria: * Concurrent life threatening condition. * Immuno-compromised subjects, concomittant immuno-suppresive treatment. * Concomitant antimicrobial treatment for CDAD. * Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol

Locations (23)

Clinical Investigative Site 6902

Newark, Delaware, United States

Outcomes

Primary Outcomes

Clinical cure rate at test-of-cure

Percentages of subjects with clinical cure are calculated, with clinical cure being defined as resolution of diarrhea with no further Clostridium Difficile-associated diarrhea (CDAD) treatment required at test-of-cure (TOC) visit. Resolution of diarrhea was defined as the occurrence of ≤ 2 semi-formed or formed stools during 24 h for at least 2 consecutive 24 h periods.

Time frame: Day 13 or 24-72 hours after end of treatment

Secondary Outcomes

Recurrence rate

Percentages of subjects with recurrence are calculated, with recurrence being defined as the occurrence of diarrhea (\> 3 liquid or unformed stools within 24 h associated with positive C. difficile toxin A/B assay) within 4 weeks after EOT in subjects clinically cured (at test-of-cure).

Time frame: Between Day 13 and Day 41 (within 4 weeks after end of treatment)

Sustained cure rate

Percentages of subjects with sustained cure are calculated, with sustained cure being defined as clinical cure without CDAD recurrence up to the end of study

Time frame: Between Day 13 and day 41 (within 4 weeks after end of treatment)

Time to resolution of diarrhea

Time to resolution of diarrhea was defined as the time (h) from the first intake of study treatment to the time (occurrence) of the first stool meeting the criteria for resolution of diarrhea up to test-of-cure.

Time frame: From Day 1 up to Day 13 (or 24-72 hours after end of treatment)

Incidence of treatment-emergent adverse events

Percentage of subjects with any adverse events in each group from first study treatment intake up to 3 days after last study drug intake

Time frame: From Day 1 to Day 14

Data from ClinicalTrials.gov

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