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.
|
NEWS HIGHLIGHTS
Published Studies Related to Bactrim IV (Trimethoprim and Sulfamethoxazole)
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.
Randomized controlled trial of pyrimethamine plus sulfadiazine versus trimethoprim plus sulfamethoxazole for treatment of toxoplasmic encephalitis in AIDS patients. [2008.03]
Background: Toxoplasmic encephalitis (TE), caused by Toxoplasma gondii, is common in AIDS patients... Conclusions: Available data suggest that of the currently available options, treatment of TE with pyrimethamine at 50 mg/day plus sulfadiazidine at 4 g/day provides the best primary outcome for AIDS patients with TE; however, because this study was terminated prematurely, we suggest that treatment with intravenous TMP-SMX be further evaluated to determine its efficacy.
Simultaneous determination of sulfamethoxazole and trimethoprim in biological fluids for high-throughput analysis: comparison of HPLC with ultraviolet and tandem mass spectrometric detection. [2008.02.15]
The comparison of two methods based on online solid phase extraction-liquid chromatography with UV (SPE-LC-UV) or mass spectrometry detection (SPE-LC-MS/MS) for the simultaneous quantification of sulfamethoxazole (SMZ) and trimethoprim (TMP) is presented.The method with MS detection in comparison with UV detection proved to be more rugged and was successfully applied to pharmacokinetics studies.
Randomized Controlled Trial of Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients. [2007.05.21]
Background: Toxoplasmic encephalitis (TE), caused by Toxoplasma gondii, is common in AIDS patients... Conclusions: Available data suggest that of the currently available options, treatment of TE with pyrimethamine at 50 mg/day plus sulfadiazidine at 4 g/day provides the best primary outcome for AIDS patients with TE; however, because this study was terminated prematurely, we suggest that treatment with intravenous TMP-SMX be further evaluated to determine its efficacy.
Clinical Trials Related to Bactrim IV (Trimethoprim and Sulfamethoxazole)
DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP) [Suspended]
Cotrimoxazole Prophylaxis in Severely Malnourished Children [Not yet 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.
Daily Co-Trimoxazole Prophylaxis to Prevent Malaria in Pregnancy [Recruiting]
Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women
and children are the most vulnerable population. Malaria in pregnancy increases the risks of
abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and
infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive
Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia
are recommended.
HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also
of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine
sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety
in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a
documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative:
many studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV
infected persons, and CTX prophylaxis significantly improves birth outcomes in
immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness
for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we
aim to establish the safety and efficacy of daily CTX in preventing malaria infection during
pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This
information is urgently needed to assist to issue guidelines on IPT in pregnancy.
Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance [Completed]
At least three studies in sub-Saharan Africa have demonstrated a decrease in morbidity or
mortality among HIV-infected adults who took daily cotrimoxazole (trimethoprim
sulfamethoxazole) [CTX] prophylaxis. Because of the demonstrated beneficial effect, high
tolerability and low cost of CTX, the United Nations Programme on HIV/AIDS (UNAIDS)
recommends that HIV-infected persons with symptomatic HIV or depressed CD4 counts receive
daily CTX. The effect of this recommendation on subsequent development of antimicrobial
resistance to antifolates among important pathogens needs to be evaluated. The
investigators measured the change in the prevalence of markers of antifolate resistance among
P. falciparum, and the change in the prevalence of CTX resistance among S. pneumoniae, and E.
coli in HIV-infected individuals receiving CTX daily prophylaxis. In addition, the
investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal
carriage of CTX resistant S. pneumoniae among children living in households where an
HIV-infected adult was receiving CTX daily prophylaxis.
A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome [Completed]
The primary objective of the study is to evaluate the effectiveness of l-leucovorin in
preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a
therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.
|
|
|
|
Page last updated: 2009-10-20
|
