Sulfamethoxazole

Generic Name: Sulfamethoxazole

Brand Names: Bactrim, Septra, Sulfatrim

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₁N_₃O_₃S

CAS Number: 723-46-6

Unique Ingredient Identifier: JE42381TNV

Background: Sulfamethoxazole is a bacteriostatic sulfonamide antibiotic that interferes with folic acid synthesis in susceptible bacteria. It is generally given in combination with trimethoprim, which inhibits a sequential step in bacterial folic acid synthesis - these agents work synergistically to block two consecutive steps in the biosynthesis of nucleic acids and proteins which are necessary for bacterial growth and division, and using them in conjunction helps to slow the development of bacterial resistance. In this combination, sulfamethoxazole is useful for the treatment of a variety of bacterial infections, including those of the urinary, respiratory, and gastrointestinal tracts.

Indication: Sulfamethoxazole is indicated in combination with trimethoprim, in various formulations, for the following infections caused by bacteria with documented susceptibility: urinary tract infections, acute otitis media in pediatric patients (when clinically indicated), acute exacerbations of chronic bronchitis in adults, enteritis caused by susceptible Shigella, prophylaxis and treatment of Pneumocystis jiroveci pneumonia, and travelers' diarrhea caused by enterotoxigenic E. coli.

In Canada, additional indications include the adjunctive treatment of cholera, treatment of bacillary dysentery, nocardiosis, and second-line treatment of brucellosis in combination with gentamicin or rifampicin.

Associated Conditions: Acute Exacerbation of Chronic Bronchitis (AECB) caused by susceptible bacteria, Acute Otitis Media caused by susceptible bacteria, Brucellosis, Dysentery, Bacillary, Nocardiosis, Pneumocystis Jirovecii Pneumonia, Urinary Tract Infection caused by susceptible bacteria, Susceptible Cholera, Susceptible Enteritis infectious caused by Shigella flexneri, Susceptible Enteritis infectious caused by Shigella sonnei, Susceptible Travelers' Diarrhea caused by Enterotoxigenic E. Coli (ETEC) Infection

Clinical Trials

A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

Completed

Conditions: Bronchitis

Interventions: Drug: Guaifenesin
Drug: Sulfamethoxazole
Drug: Trimethoprim

First Posted Date: 2016-08-26

Last Posted Date: 2019-12-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 51

Registration Number: NCT02879981

Locations: 🇵🇪
Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica, La Victoria, Peru
🇵🇪
Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA, San Isidro, Peru
🇵🇪
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional, Lima, Peru

Sulfamethoxazole for the Treatment of Primary PREPL Deficiency

Phase 2

Conditions: Hypotonia Cystinuria Syndrome
Isolated PREPL Deficiency

Interventions: Drug: Sulfamethoxazole

First Posted Date: 2015-12-29

Last Posted Date: 2015-12-29

Lead Sponsor: Universitair Ziekenhuis Brussel

Target Recruit Count: 15

Registration Number: NCT02640443

Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

Not Applicable

Completed

Conditions: Hypospadias

Interventions: Drug: Septra

First Posted Date: 2015-11-01

Last Posted Date: 2018-11-05

Lead Sponsor: Medical College of Wisconsin

Target Recruit Count: 67

Registration Number: NCT02593903

Locations: 🇺🇸
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

Efficacy of Fosfomycin-Trometamol in Urinary Tract Infection Prophylaxis After Kidney Transplantation

Phase 4

Completed

Conditions: Urinary Tract Infection
Asymptomatic Bacteriuria
Allograft Rejection
Microbiologic Resistance
Hospitalization

Interventions: Drug: Fosfomycin-Trometamol
Drug: Sulfamethoxazole trimethoprim

First Posted Date: 2013-03-29

Last Posted Date: 2015-03-26

Lead Sponsor: JOSE MANUEL ARREOLA GUERRA

Target Recruit Count: 130

Registration Number: NCT01820897

Locations: 🇲🇽
National Institute of Medical Science and Nutrition Salvador Zubiran, México, Mexico DF, Mexico
🇲🇽
National Institute of Medical Sciences and Nutrition Salvador Zubiran, Mexico city, Distrito Federal, Mexico

Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection

Phase 2

Conditions: Hip Prosthetic Joint Infection

Interventions: Drug: VANCOMYCIN
Drug: CEFTRIAXONE
Drug: LINEZOLID
Drug: CLINDAMYCIN
Drug: SULFAMETHOXAZOLE AND TRIMETHOPRIM (CO-TRIMOXAZOLE)
Drug: FLUOROQUINOLONE
Drug: RIFAMPIN

First Posted Date: 2012-12-28

Last Posted Date: 2014-05-28

Lead Sponsor: University Hospital, Tours

Target Recruit Count: 100

Registration Number: NCT01757236

Locations: 🇫🇷
CHRU de Tours, Tours, Indre et Loire, France
🇮🇹
Azienda Opedaliera Universitaria San Maria della Misericordia, Udine, Italy
🇫🇷
CHU de Nantes, Nantes, France

and more 6 locations

New Mexico Honey Wound Treatment Research Study

Phase 2

Conditions: Community-acquired Methicillin-resistant Staphylococcus Aureus Infection

Interventions: Drug: New Mexico Honey
Drug: Bactrim DS

First Posted Date: 2012-12-12

Last Posted Date: 2016-05-10

Lead Sponsor: R. Stephen Rankin, M.D.

Target Recruit Count: 60

Registration Number: NCT01748318

Locations: 🇺🇸
Pinon Family Practice, Farmington, New Mexico, United States

Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Sulfamethoxazole + MMX Mesalazine/mesalamine
Drug: sulfamethoxazole + MMX placebo

First Posted Date: 2011-11-10

Last Posted Date: 2021-07-13

Lead Sponsor: Shire

Target Recruit Count: 44

Registration Number: NCT01469637

Locations: 🇺🇸
PRA Inrernational, Lenexa, Kansas, United States

Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Not Applicable

Conditions: Osteomyelitis
Diabetic Foot
Diabetic Foot Ulcers

Interventions: Drug: Ciprofloxacin
Procedure: Conservative surgery
Drug: Amoxicillin-Potassium Clavulanate Combination
Drug: Sulfamethoxazole trimethoprim