Cephalexin for Genetic Predisposition to Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California, San Francisco, San Francisco, CA
Genetic Predisposition to Disease+5 More
Cephalexin - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether there is a relationship between the microbiome of breast tissue and the development of tissue expander-related infections.

See full description

Eligible Conditions

  • Genetic Predisposition to Disease
  • Malignant Neoplasm of Female Breast
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Genetic Predisposition to Disease

Study Objectives

This trial is evaluating whether Cephalexin will improve 6 primary outcomes and 4 secondary outcomes in patients with Genetic Predisposition to Disease. Measurement will happen over the course of 90 days.

90 days
Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)
Number of overall identified microbes
Proportion of any samples successfully producing microbiome data
Proportion of aspirate samples obtained successfully overall
Proportion of aspirate samples successfully producing microbiome data
Proportion of participants with post-operative infection
Proportion of tissue samples obtained successfully over time
Proportion of tissue samples successfully producing microbiome data
Shannon Diversity Index Score for species of microbiome
Shanon Index Score for species of microbiome

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Genetic Predisposition to Disease

Side Effects for

Cellulitis, Cephalexin and TMP/SMX
Diarrhoea
22%
Nausea
20%
Headache
17%
Cellulitis
11%
Abscess
11%
Vomiting
8%
Abdominal pain upper
8%
Dizziness
7%
Rash
6%
Pyrexia
5%
Constipation
3%
Breast abscess
0%
Bursitis infective
0%
Bradycardia
0%
Diverticulitis
0%
Suicidal ideation
0%
Angioedema
0%
Pancytopenia
0%
Suicide attempt
0%
Renal failure acute
0%
Pulmonary embolism
0%
Gastroenteritis
0%
Wound infection
0%
Periorbital cellulitis
0%
Chronic obstructive pulmonary disease
0%
Lip injury
0%
Diabetic ketoacidosis
0%
Asthma
0%
Mental disorder
0%
Coccidioidomycosis
0%
Pneumonia
0%
Anal fistula
0%
Acidosis
0%
Road traffic accident
0%
Wound complication
0%
Appendicitis
0%
Necrotising fasciitis
0%
Hyperglycaemia
0%
Depression
0%
Acute coronary syndrome
0%
Cardiomyopathy
0%
Myocardial infarction
0%
Abdominal pain
0%
Death
0%
Abscess limb
0%
Chest pain
0%
Osteomyelitis
0%
Clostridium difficile colitis
0%
Cellulitis staphylococcal
0%
Localised infection
0%
Pyelonephritis
0%
Infection
0%
Viral infection
0%
Sepsis
0%
Skin infection
0%
Drug dependence
0%
Hypertension
0%
Deep vein thrombosis
0%
Renal failure
0%
This histogram enumerates side effects from a completed 2013 Phase 2 & 3 trial (NCT00729937) in the Cellulitis, Cephalexin and TMP/SMX ARM group. Side effects include: Diarrhoea with 22%, Nausea with 20%, Headache with 17%, Cellulitis with 11%, Abscess with 11%.

Trial Design

2 Treatment Groups

Cohort B: No antibiotics
1 of 2
Cohort A: Standard antibiotics
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cephalexin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort A: Standard antibiotics
Drug
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively
Cohort B: No antibioticsReceive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cephalexin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histologically confirmed breast malignancy
Age >= 18 years
Scheduled to undergo mastectomy with the immediate placement of tissue expanders
Ability to understand a written informed consent document, and the willingness to sign it
At least 4 weeks post-completion of chemotherapy

Patient Q&A Section

Who should consider clinical trials for infections?

"Clinical trial participation has increased over time and is now recommended for all patients when the cost-effectiveness of treatment outweighs the potential risks. Patients with concerns about the prolonged length of some treatments, or other severe side effects, may be less likely to participate, but this decision needs to be made in consultation with their clinician." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving cephalexin?

"Limited data suggest that cephalexin may be effective against infections caused by Enterobacteriaceae, Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Staphylococcus aureus. More research is needed to evaluate whether cephalexin has any effect against methicillin-resistant "Staphylococcus aureus" (MRSA), carbapenem-resistant P. aeruginosa, and vancomycin-resistant enterococci." - Anonymous Online Contributor

Unverified Answer

Does cephalexin improve quality of life for those with infections?

"Cephalexin improved health related quality of life in patients with respiratory tract infections. The use of cephalexin decreased patient's perception of symptoms when compared with placebo." - Anonymous Online Contributor

Unverified Answer

How quickly does infections spread?

""Time to infection" is an important concept for health systems practitioners and public health workers. In reality however, it takes time to identify and control infections and to develop effective interventions that prevent them, especially when these are difficult to implement due to their complexity and cost. We discuss current evidence regarding the transmission of infectious diseases, and propose metrics and approaches that are useful for monitoring the effectiveness of such strategies within a health system context." - Anonymous Online Contributor

Unverified Answer

What is cephalexin?

"Cephalexin is a broad spectrum antibiotic. It is used to treat bacterial infections of the urinary tract including cystitis, pyelonephritis, and bacteremia. Cephalexin is also effective against "Clostridium difficile" infection. Cephalexin is also effective for treating many penicillin allergies. Cephalexin is absorbed slowly through the GI tract, so it takes longer than other antibiotics to reach peak blood plasma concentrations. For this reason, cephalexin is often given as a single low dose instead of a course of treatment. The drug should be taken at least an hour before food to delay absorption." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in cephalexin for therapeutic use?

"Cephalexin for therapeutic use is an effective antimicrobial agent against Gram-positive and gram-negative bacteria. It was first introduced in Japan in 1955 and its combination therapy with amoxicillin was approved by the FDA in 1965. At present, a combination therapy with cephalexin and penicillin G is widely used for treating infections caused by aerobic streptococci in hospitals. In addition, topical cephalexin ointment is widely used for treating bacterial skin infections such as impetigo bacillus, dermatophytosis and staphylococcal scalded skin syndrome. Because of these advantages, cephalexin is considered suitable for developing oral preparations." - Anonymous Online Contributor

Unverified Answer

How does cephalexin work?

"Cephalexin has demonstrated clinically beneficial effects in treating acute bacterial sinusitis. The mechanism responsible for its efficacy remains unknown. In vitro studies have shown that cephalexin alters membrane fluidity and permeability, which could account for its antibacterial activity." - Anonymous Online Contributor

Unverified Answer

What are common treatments for infections?

"These treatments can be used to treat common infections such as herpes simplex, hepatitis A, influenza, chlamydia, HIV, and tuberculosis. Most patients will see their doctor, who can prescribe medication or make recommendations on how to take them." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets infections?

"There is no standard definition of what ages mean when referring to people getting infections. Findings from a recent study shows that infections of many types occur across all ages (see table below). In this article we discuss how different age definitions may affect which diseases appear to be more common in certain groups of children. We also consider whether our attitudes and behaviors towards infectious diseases change according to age group." - Anonymous Online Contributor

Unverified Answer

How many people get infections a year in the United States?

"The overall prevalence of HAI and pneumonia among hospitalized adults was 11% and 9%, respectively; rates were highest among those with diabetes and Medicare insurance. Increased efforts are needed to improve HAI prophylaxis and adherence to guidelines in the prevention and management of HAI." - Anonymous Online Contributor

Unverified Answer

Is cephalexin typically used in combination with any other treatments?

"The use of cephalexin in combination with antibiotics in patients hospitalized for pneumonia has been shown to decrease the risk of bacterial resistance to both cephalosporins and penicillins. Cephalexin should remain an important option in the empiric treatment of serious infections, particularly when carbapenem-resistant Gram-negative bacteria are suspected." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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