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Antibiotic

DNV3837 for C. Difficile

Phase 2

Recruiting

Research Sponsored by Deinove

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

Study Summary

This trial is testing a new drug, DNV3837, to see if it is safe and effective in treating people with Clostridium difficile infection (CDI). The study will be conducted in two parts, with a total of 40 subjects enrolled. Part 1 will enroll 10 subjects and Part 2 will enroll up to 30 subjects. Treatment will consist of a daily IV infusion for 10 days. The objectives of the study are to evaluate the safety and efficacy of DNV3837, assess the drug's pharmacokinetics, and assess changes in the gut microbiome.

Eligible Conditions

C. Difficile

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

All-Cause Mortality

Clostridium difficile Infection attributable mortality

Incidence of relapse at Test of Cure

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2Experimental Treatment1 Intervention

30 subjects with severe or non-severe CDI will be enrolled to receive DNV3837. Treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total daily dose of 1.5 mg/kg actual body weight(BW)/day DNV3837. Infusions will be administered once daily for 10 consecutive days

Group II: Part 1Experimental Treatment1 Intervention

10 subjects of either sex with severe or non-severe CDI will be enrolled to receive DNV3837. Treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total daily dose of 1.5 mg/kg actual body weight(BW)/day DNV3837. Infusions will be administered once daily for 10 consecutive days.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

DeinoveLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any known DNV3837 side effects in human beings?

"While there is some evidence to support the safety of DNV3837, it only received a score of 2 because there are no data points affirming its efficacy."

Answered by AI

Are researchers still looking for test subjects for this experiment?

"This study appears to be actively recruiting patients, according to the information on clinicaltrials.gov. The listing for this trial was first posted on 8/2/2019 and was last updated on 9/6/2022."

Answered by AI

What is the total number of people taking part in this experiment?

"To complete this clinical trial, 40 eligible patients must be enrolled by the sponsor, Deinove. The research will take place across different locations, such as Mercury Street Medical in Butte and UC Davis Medical Center in Sacramento."

Answered by AI

Is this study only being conducted in North American hospitals?

"There are 7 clinical trial sites including Mercury Street Medical in Butte, University of California (UC) Davis Medical Center in Sacramento, and Snake River Research, PLLC in Idaho Falls."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile Infection

2019. "An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03988855.

All > Clostridium Difficile