Is NCT06237452 recruiting in Huntsville, AL?

Yes, NCT06237452 is currently recruiting participants at its Huntsville, AL location. This c. diff infection clinical trial is actively enrolling qualified participants.

How do I join the c. diff infection clinical trial in Huntsville?

To join this clinical trial in Huntsville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Huntsville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

C. Diff Infection Clinical Trial in Huntsville, AL

About This C. Diff Infection Study in Huntsville

The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

Sponsor: Vedanta Biosciences, Inc.

Who Can Participate

Inclusion Criteria

(For enrollment in Stage 1: recurrent CDI population):

Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):

Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI

OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:

Age ≥ 65 years

Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode

History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study

History of a prior CDI episode between 6 and 12 months prior to enrollment

Immunosuppression due to an underlying disease or its treatment

Has undergone solid organ or hematopoietic stem cell transplantation Key Inclusion Criteria (For enrollment in Stage 1 or 2):

The qualifying episode of CDI must meet all the following criteria:

New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days

CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI

Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory

Diarrhea considered unlikely to have another etiology

Prior to receiving any study medication, the participant should:

Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.

Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days

Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing

Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization Key

Exclusion Criteria

(For both Stage 1 and Stage 2):

History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI

Known or suspected toxic megacolon or small bowel ileus at the time of randomization

History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis

Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode

Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug

Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)

Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.)

Absolute neutrophil count (ANC) of \< 0.5 ×10\^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \< 1.0 × 10\^9 cells/L

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Huntsville?

Yes, this clinical trial (NCT06237452) has an active research site in Huntsville, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

C. Diff Infection Treatment Options in Huntsville, AL

If you're searching for c. diff infection treatment options in Huntsville, AL, this clinical trial (NCT06237452) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Huntsville research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced c. diff infection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all c. diff infection clinical trials near you to find additional studies recruiting in your area.

C. Diff Infection Clinical Trial in Huntsville, AL

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