Cephalexin

Generic Name: Cephalexin

Brand Names: Keflex

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₇N_₃O_₄S

CAS Number: 15686-71-2

Unique Ingredient Identifier: 5SFF1W6677

Background: Cephalexin is the first of the first generation cephalosporins. This antibiotic contains a beta lactam and a dihydrothiazide. Cephalexin is used to treat a number of susceptible bacterial infections through inhibition of cell wall synthesis. Cephalexin was approved by the FDA on 4 January 1971.

Indication: Cephalexin is indicated for the treatment of certain infections caused by susceptible bacteria. These infections include respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections.

Associated Conditions: Bone Infection, Genitourinary tract infection, Otitis Media (OM), Respiratory Tract Infections (RTI), Skin and skin structure infections, Acute Prostatitis

Clinical Trials

Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules

Phase 1

Completed

Conditions: Anti-Infective Agents

Interventions: Drug: Cephalexin capsules (Optocef, BAYO5448 )
Drug: Cephalexin capsules (Keflex)

First Posted Date: 2010-02-23

Last Posted Date: 2015-04-03

Lead Sponsor: Bayer

Target Recruit Count: 26

Registration Number: NCT01073553

Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

Phase 3

Completed

Conditions: Arrythmias

Interventions: Drug: Cefazolin, Bacitracin, Cefalexin
Drug: Cefazolin

First Posted Date: 2009-10-28

Last Posted Date: 2013-05-16

Lead Sponsor: Population Health Research Institute

Target Recruit Count: 500

Registration Number: NCT01002911

Locations: 🇨🇦
Institut universitaire de cardiologie et de pneumologie de Quebec, Ste-Foy, Quebec, Canada

Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip

Not Applicable

Terminated

Conditions: Through-and-through Lip Lacerations

Interventions: Drug: placebo
Drug: keflex

First Posted Date: 2009-08-12

Last Posted Date: 2019-04-16

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 4

Registration Number: NCT00957827

Locations: 🇺🇸
Hopital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"

Phase 2

Completed

Conditions: Staphylococcal Infection

Interventions: Other: Placebo
Drug: Clindamycin
Drug: Cephalexin
Drug: Trimethoprim-sulfamethoxazole

First Posted Date: 2008-08-08

Last Posted Date: 2015-02-18

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 2265

Registration Number: NCT00729937

Locations: 🇺🇸
University of California Los Angeles - Olive View Medical Center, Sylmar, California, United States
🇺🇸
Maricopa Medical Center - Emergency Medicine, Phoenix, Arizona, United States
🇺🇸
Johns Hopkins University at Mount Washington - Emergency Medicine, Baltimore, Maryland, United States

and more 2 locations

Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients

Not Applicable

Completed

Conditions: Cellulitis

Interventions: Drug: Cephalexin
Drug: trimethoprim-sulfamethoxazole

First Posted Date: 2008-05-12

Last Posted Date: 2012-08-14

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 153

Registration Number: NCT00676130

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Children's Hospital Boston, Boston, Massachusetts, United States

Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections

Phase 4

Completed

Conditions: Staphylococcal Infection
Abscess
Staphylococcal Skin Infection
Folliculitis

Interventions: Drug: cephalexin
Drug: clindamycin

First Posted Date: 2006-07-14

Last Posted Date: 2013-05-13

Lead Sponsor: Aaron Chen

Target Recruit Count: 200

Registration Number: NCT00352612

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections

Phase 4

Completed

Conditions: Mild to Moderate Uncomplicated Skin and Skin Structure Infections

First Posted Date: 2005-10-10

Last Posted Date: 2007-10-25

Lead Sponsor: Abbott

Target Recruit Count: 380

Registration Number: NCT00234949

Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection

Not Applicable

Completed

Conditions: Soft Tissue Infections

First Posted Date: 2005-09-16

Last Posted Date: 2015-05-07

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 500

Registration Number: NCT00187759

Locations: 🇺🇸
San Francisco General Hospital, San Francisco, California, United States

S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer

Phase 3

Terminated

Conditions: Bladder Cancer

Interventions: Procedure: surgical procedure
Drug: cephalexin
Drug: Ciprofloxacin

First Posted Date: 2004-04-14

Last Posted Date: 2012-03-09

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 114

Registration Number: NCT00003824

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
🇺🇸
Providence Hospital - Southfield, Southfield, Michigan, United States

and more 87 locations

Drug Development Updates

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