BACTRIM IV SUMMARY
Bactrim (trimethoprim and sulfamethoxazole) IV Infusion, a sterile solution
for intravenous infusion only, is a synthetic antibacterial combination product.
Pneumocystis Carinii Pneumonia: Bactrim IV Infusion is indicated in
the treatment of Pneumocystis carinii pneumonia in children and adults.
Shigellosis: Bactrim IV Infusion is indicated in the treatment
of enteritis caused by susceptible strains of Shigella flexneri and Shigella
sonnei in children and adults. Urinary Tract Infections: Bactrim IV Infusion is indicated
in the treatment of severe or complicated urinary tract infections due to susceptible
strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii and Proteus species when oral administration
of Bactrim is not feasible and when the organism is not susceptible to single-agent
antibacterials effective in the urinary tract.
Although appropriate culture and susceptibility studies should be performed,
therapy may be started while awaiting the results of these studies.
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NEWS HIGHLIGHTS
Published Studies Related to Bactrim IV (Trimethoprim and Sulfamethoxazole)
Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. [2010.09]
STUDY OBJECTIVE: Community-associated methicillin-resistant Staphylococcus aureus is now the leading cause of uncomplicated skin abscesses in the United States, and the role of antibiotics is controversial. We evaluate whether trimethoprim-sulfamethoxazole reduces the rate of treatment failures during the 7 days after incision and drainage and whether it reduces new lesion formation within 30 days... CONCLUSION: After the incision and drainage of uncomplicated abscesses in adults, treatment with trimethoprim-sulfamethoxazole does not reduce treatment failure but may decrease the formation of subsequent lesions. Copyright (c) 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.
Standard versus newer antibacterial agents in the treatment of severe acute exacerbation of chronic obstructive pulmonary disease: a randomized trial of trimethoprim-sulfamethoxazole versus ciprofloxacin. [2010.07.15]
BACKGROUND. Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiotic has any impact on outcome.
Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated
skin abscesses in patients at risk for community-associated methicillin-resistant
Staphylococcus aureus infection. [2010]
within 30 days... CONCLUSION: After the incision and drainage of uncomplicated abscesses in adults,
Effect of long-term trimethoprim/sulfamethoxazole treatment on resistance and integron prevalence in the intestinal flora: a randomized, double-blind, placebo-controlled trial in children. [2009.05]
OBJECTIVES: The aim of this study was to test the hypothesis that trimethoprim/sulfamethoxazole selects for integron-positive and multidrug-resistant Enterobacteriaceae in the intestinal flora... CONCLUSIONS: Initially, trimethoprim/sulfamethoxazole usage was strongly associated with the appearance of integron-positive (multi)drug-resistant Enterobacteriaceae in the intestinal flora. After prolonged exposure to trimethoprim/sulfamethoxazole, however, this population of Enterobacteriaceae was substituted by a population with non-integron-associated resistance mechanisms. After trimethoprim/sulfamethoxazole was discontinued, susceptibility rates to all antibiotics returned to baseline levels.
Trimethoprim-sulfamethoxazole in children with chronic otitis media: a randomized comparison of costs and effects. [2008.10]
OBJECTIVE: To study the cost-effectiveness of a 6- to 12-week course of high-dose oral trimethoprim-sulfamethoxazole in children with chronic active otitis media (COM)... CONCLUSION: In children with active COM, direct and indirect costs of a 6- to 12-week course of high-dose oral trimethoprim-sulfamethoxazole are modest in the light of its short-term clinical benefit.
Clinical Trials Related to Bactrim IV (Trimethoprim and Sulfamethoxazole)
Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole [Not yet recruiting]
First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which
causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole.
Cotrimoxazole may improve the clinical course of the disease through eradication of
Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of
alveolar macrophages and producing alterations in the surfactant system which favours the
persistent activation of the inflammatory response and the development of pulmonary
fibrosis.
Cotrimoxazole Prophylaxis in Severely Malnourished Children [Recruiting]
This trial aims to test the hypothesis that mortality among Kenyan children with severe
malnutrition following initial stabilisation is due to ongoing vulnerability to infectious
disease, and that co-trimoxazole prophylaxis will reduce mortality.
The objective is to conduct a randomized, double blind, placebo-controlled trial of
cotrimoxazole prophylaxis for 6 months among HIV-uninfected children with severe
malnutrition following stabilization. The primary outcome will be survival at one year.
Secondary outcomes are toxicity, survival at two years, growth, hospitalisation and
microbial resistance and ecology.
Cotrimoxazole has striking protective efficacy against mortality among children with HIV,
despite not altering the underlying immune deficiency. It is hypothesised that
co-trimoxazole prophylaxis will have a similar effect in children immunocompromised because
of severe malnutrition. Worldwide, severe malnutrition is commoner than HIV in childhood and
co-trimoxazole is cheap and widely available, making it easily translatable to policy.
Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients [Recruiting]
The primary aim of this study is to quantify the effectiveness of Bactrim as additional
therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard
therapy plus Bactrim, versus standard therapy plus placebo.
The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence,
subjects treated with standard therapy plus Bactrim will have higher cure rates than those
treated with standard therapy plus placebo.
Co-trimoxazole as Maintenance Therapy for Meliodosis [Not yet recruiting]
This is a randomised, open-labelled, controlled trial to compare the efficacy and
effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of
melioidosis. The study population includes 800 patients with culture-confirmed melioidosis
whom intravenous intensive antibiotics and 12 weeks of oral eradication therapy have been
completed. Patients will be randomised to either stop the eradication treatment or continue
current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat
melioidosis for better compliance and reducing unnecessary use of antibiotics.
Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections [Recruiting]
Methicillin-resistant Staphylococcus aureus (SA) is a major pathogen causing mainly
health-care associated infections and, lately, also community acquired infections. Few
treatment choices exist to treat these infections. The currently recommended antibiotics for
these infections are glycopeptides (vancomycin or teicoplanin). Glycopeptide treatment hs
several disadvantages. It is a last resort antibiotic family that should be reserved for the
future; Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to
both agents; treatment can only be given intravenously; and use of vancomycin has led to the
development of SA strains with partial or complete resistance to vancomycin. Cotrimoxazole
is an old antibiotic active against most strains of MRSA, depending on local epidemiology.
Study hypothesis: The purpose of this study is to show that cotrimoxazole is as effective as
treatment with vancomycin for invasive MRSA infections.
We plan a randomized controlled trial comparing treatment with cotrimoxazole vs. vancomycin
for invasive MRSA infections. The primary efficacy outcome we will assess will be
Improvement or cure with or without antibiotic modifications, defined as: survival at 7 days
post randomization with resolution of fever (<38 for two consecutive days) and resolution of
hypotension (>90 systolic without need for vasopressor support); and physician's assessment
that the primary infection was improved or cured. The primary safety outcome will be
all-cause 30-day survival.
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