What side effects are associated with this type of intervention?

Common side effects of antibiotic prophylaxis include gastrointestinal disturbances such as nausea, vomiting, and diarrhea. Allergic reactions, ranging from mild skin rashes to severe anaphylaxis, can also occur. Additionally, the use of antibiotics can lead to the development of antibiotic-resistant bacteria, which is a significant public health concern. In the context of prophylactic antibiotics for bladder Botox injections, these side effects remain relevant, and careful consideration is needed to balance the benefits and risks.

What prior FDA approvals exist?

The FDA has approved several antibiotics for prophylactic use to prevent bacterial infections in various medical and surgical settings. Commonly approved antibiotics include cephalosporins (e.g., cefazolin) for preoperative prophylaxis in surgeries such as breast and orthopedic procedures. Additionally, carbapenems (e.g., imipenem, meropenem) and beta-lactam/beta-lactamase inhibitor combinations (e.g., piperacillin-tazobactam) are used for prophylaxis in high-risk abdominal surgeries and conditions like necrotizing pancreatitis. These antibiotics are chosen based on their broad-spectrum activity and effectiveness in reducing postoperative infections.

What other types of research exist?

Promising alternatives to antibiotic prophylaxis for preventing bacterial infections include the use of vaccines to boost immunity against specific pathogens, bacteriophage therapy to target and destroy bacteria, probiotics to maintain a healthy microbiome, and immune modulation strategies to enhance the body's natural defenses. Additionally, advancements in antimicrobial coatings for medical devices and novel drug delivery systems are being explored to reduce infection risks without relying on traditional antibiotics.

← Back to Search

Prophylactic Antibiotics Before Botox Injections for Antibiotic Prophylaxis

Phase 4

Recruiting

Led By Carolyn Botros, DO

Research Sponsored by Atlantic Health System

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 6 weeks

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing if patients getting bladder injections need antibiotics to prevent infections. The goal is to see if skipping antibiotics is just as safe, which could help reduce unnecessary antibiotic use. Patients will be monitored for infection symptoms to compare those who took antibiotics and those who did not. This treatment is increasingly used for overactive bladder and neurogenic bladder.

Who is the study for?

This trial is for women aged 18 or older who are undergoing bladder Botox treatments. They must be able to take oral medication and not have allergies to antibiotics or Botox components. Participants should not have urinary retention issues, be pregnant, or breastfeeding.

What is being tested?

The study compares the effect of taking Nitrofurantoin antibiotics before and after bladder Botox injections versus no antibiotic use at all. The goal is to see if skipping antibiotics doesn't increase UTI risk, which could help fight antibiotic resistance.

What are the potential side effects?

Potential side effects from Nitrofurantoin may include digestive upset, headache, dizziness, and lung problems. Allergic reactions can occur but only participants without known hypersensitivity will be included.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Urinary tract infections

Other study objectives

Urinary retention and adverse reactions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Antibiotic armExperimental Treatment1 Intervention

Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.

Group II: No treatment armActive Control1 Intervention

No antibiotics administered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitrofurantoin

2011

Completed Phase 4

~4100

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibiotic prophylaxis involves the use of antibiotics to prevent bacterial infections by either inhibiting bacterial growth or killing bacteria. Common antibiotics used for prophylaxis include fluoroquinolones and trimethoprim-sulfamethoxazole. Fluoroquinolones work by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes critical for DNA replication and transcription, leading to bacterial cell death. Trimethoprim-sulfamethoxazole inhibits bacterial folic acid synthesis, which is essential for DNA, RNA, and protein production, thereby preventing bacterial growth. These mechanisms are crucial for patients undergoing antibiotic prophylaxis as they help reduce the risk of infections during medical procedures, thereby improving patient outcomes and preventing complications.