Cefotetan for E. coli Infections

JL
KL
Overseen ByKristina L. Bajema
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of cefotetan for treating E. coli infections in the blood or urinary system. Researchers aim to determine if cefotetan outperforms the usual antibiotics for these infections. The trial will also assess the dosage required to stop the bacteria and how the body processes the drug. Individuals who have recently started antibiotics for a urinary E. coli infection and whose infection can be treated with cefotetan are suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that cefotetan is likely to be safe for humans?

Research has shown that cefotetan is generally safe for people. The FDA has already approved it to treat various infections, including those caused by E. coli, indicating it has undergone safety testing for these cases.

Common side effects include diarrhea, nausea, and pain at the injection site, typical for many antibiotics. Serious side effects are rare but may include allergic reactions.

This trial examines how cefotetan compares to standard antibiotics for E. coli infections in the blood and urinary system. Since it is already approved, strong evidence suggests it is safe for most people. However, as with any medication, individual reactions can vary.12345

Why do researchers think this study treatment might be promising?

Cefotetan is unique because it offers a different approach to treating E. coli infections compared to standard antibiotics like ciprofloxacin and trimethoprim-sulfamethoxazole. While most antibiotics work by inhibiting bacterial growth, cefotetan belongs to the cephalosporin class, which targets and disrupts the bacterial cell wall, leading to the destruction of the bacteria. This mechanism can be particularly effective against resistant strains of E. coli, which are becoming more common. Researchers are excited about cefotetan because it could provide a more reliable and potent option for tackling these tough infections.

What evidence suggests that cefotetan might be an effective treatment for E. coli infections?

Research has shown that cefotetan, which participants in this trial may receive, is very effective in the lab against E. coli, a common bacteria that causes infections. Studies have found that cefotetan works well against E. coli strains that produce ESBL, an enzyme that makes bacteria resistant to many antibiotics. The MIC values, which indicate the amount of antibiotic needed to stop bacteria from growing, demonstrate cefotetan's effectiveness even at low doses. This suggests cefotetan could be a promising option for treating E. coli infections, especially when other antibiotics might not work as well. Overall, these findings provide strong evidence of cefotetan’s potential effectiveness.26789

Are You a Good Fit for This Trial?

This trial is for hospitalized patients who have E. coli infections in their blood or urinary tract, identified within 48 hours of starting antibiotics. They must be able to consent and have an infection that responds to the study drugs but can't join if they're allergic to cefotetan, pregnant, breastfeeding, previously had certain blood reactions to cephalosporins, severely ill or immunocompromised.

Inclusion Criteria

Identified within 48 hours of inpatient antibiotic administration for acute illness
Patient or legally authorized representative are able to provide informed consent for participation in the study
I have a blood infection caused by E. coli from a urinary source.
See 1 more

Exclusion Criteria

Allergy to cefotetan
Pregnant or breastfeeding
History of cephalosporin-associated hemolytic anemia
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either cefotetan or standard of care antibiotics for their infection

7 days
Daily monitoring (in-person)

Follow-up

Participants are monitored for clinical outcomes, including absence of death, recurrent E. coli bacteremia, or need for additional antibiotic treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Cefotetan

Trial Overview

The study compares cefotetan with standard care antibiotics (like carbapenems) for treating E. coli infections. It's a pilot study looking at how well these treatments work and measuring drug levels in the body as well as the bacteria's resistance levels.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CefotetanExperimental Treatment1 Intervention
Group II: Standard of care antibioticsActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Citations

In Vitro Activity of Cefotetan against ESBL-Producing ...

Cefotetan demonstrated favorable in vitro efficacy against ESBL-producing E. coli and K. pneumoniae bloodstream isolates with MIC50s and MIC90s of 0.25 mg/liter ...

Cefotetan Therapy for Escherichia Coli Infections

This pilot study will compare clinical outcomes among patients treated with cefotetan versus standard of care antibiotics for bacteremia or genitourinary ...

Comparative activity of cefotetan on Escherichia coli K12 ...

Abstract. The antibacterial activity of cefotetan, a new cephamycin, was compared with that of cephalothin, ccfoxitin, cefamandole, ccfopcrazonc and cefota.

Cefotetan Therapy for Escherichia Coli Infections | MedPath

This pilot study will compare clinical outcomes among patients treated with cefotetan versus standard of care antibiotics for bacteremia or ...

In Vitro Activity of Cefotetan against ESBL-Producing Escherichia ...

Cefotetan demonstrated favorable in vitro efficacy against ESBL-producing E. coli and K. pneumoniae bloodstream isolates and holds potential to be a ...

Cefotetan - accessdata.fda.gov

Intra-abdominal Infections caused by E. coli, Klebsiella species (including. K. pneumoniae), Streptococcus species (excluding enterococci), Bacteroides species.

Cefotetan: Package Insert / Prescribing Information

Cefotetan package insert / prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions and ...

(cefotetan) dosing, indications, interactions, adverse effects ...

Dosage and route of administration depends on condition of patient, severity of infection, and susceptibility of causative organism.

Cefotan: Uses, Side Effects & Dosage

Find clinical guidance on Cefotan, including indications, dosing, safety, side effects and evidence-based insights for healthcare ...