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There are limited data on the role of antimicrobials in the treatment of skin abscesses. In this trial, clindamycin or trimethoprim–sulfamethoxazole was found to facilitate more rapid resolution than placebo in the management of skin abscess under 5 cm in diameter. More than 4 in 100 people seek treatment for skin infections annually in the United States. 1 Abscesses are the most common of these infections, and the majority of patients are treated as outpatients. 1 Serious complications, such as bacteremia, occur in rare cases. 1 , 2 Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA) strains, causes most skin infections, 3 , 4 but the appropriate strategy for the treatment of these infections has not been defined. Clindamycin and trimethoprim–sulfamethoxazole (TMP-SMX) are recommended for outpatient treatment of abscesses because of their low cost and in vitro activity against community-associated MRSA and methicillin-susceptible strains, 5 but data on their . . .

In this randomized clinical trial in patients presenting to U.S. emergency departments with an acute uncomplicated cutaneous abscess, drainage plus trimethoprim–sulfamethoxazole therapy for a week was associated with modest clinical benefits as compared with drainage alone. Between 1993 and 2005, annual emergency department visits for skin and soft-tissue infections in the United States increased from 1.2 million to 3.4 million, primarily because of an increased incidence of abscesses. 1 , 2 During this period, community-associated methicillin-resistant Staphylococcus aureus (MRSA) emerged as the most common cause of purulent skin and soft-tissue infections in many parts of the world. 3 Trimethoprim–sulfamethoxazole, which has retained in vitro activity against community-associated MRSA, is among the most commonly prescribed antibiotics to treat these infections. 4 The primary treatment of a cutaneous abscess is drainage. 5 Whether adjunctive antibiotics lead to improved outcomes in patients with uncomplicated . . .

The cornerstone of malaria prevention in pregnancy, intermittent preventive treatment (IPTp) with sulfadoxine–pyrimethamine, is contraindicated in women with HIV who are receiving co-trimoxazole prophylaxis. We assessed whether IPTp with dihydroartemisinin–piperaquine is safe and effective in reducing the risk of malaria infection in women with HIV receiving co-trimoxazole prophylaxis and antiretroviral drugs. For this randomised, double-blind, placebo-controlled clinical trial, women with HIV attending the first antenatal care clinic visit, resident in the study area, and with a gestational age up to 28 weeks were enrolled at five sites in Gabon and Mozambique. Participants were randomly assigned (1:1) to receive either IPTp with dihydroartemisinin–piperaquine at each scheduled antenatal care visit plus daily co-trimoxazole (intervention group) or placebo at each scheduled antenatal care visit plus daily co-trimoxazole (control group). Randomisation was done centrally via block randomisation (block sizes of eight), stratified by country. IPTp was given over 3 days under direct observation by masked study personnel. The number of daily IPTp tablets was based on bodyweight and according to the treatment guidelines set by WHO (target dose of 4 mg/kg per day [range 2–10 mg/kg per day] of dihydroartemisinin and 18 mg/kg per day [range 16–27 mg/kg per day] of piperaquine given once a day for 3 days). At enrolment, all participants received co-trimoxazole (fixed combination drug containing 800 mg trimethoprim and 160 mg sulfamethoxazole) for daily intake. The primary study outcome was prevalence of peripheral parasitaemia detected by microscopy at delivery. The modified intention-to-treat population included all randomly assigned women who had data for the primary outcome. Secondary outcomes included frequency of adverse events, incidence of clinical malaria during pregnancy, and frequency of poor pregnancy outcomes. All study personnel, investigators, outcome assessors, data analysts, and participants were masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT03671109. From Sept 18, 2019, to Nov 26, 2021, 666 women (mean age 28·5 years [SD 6·4]) were enrolled and randomly assigned to the intervention (n=332) and control (n=334) groups. 294 women in the intervention group and 308 women in the control group had peripheral blood samples taken at delivery and were included in the primary analysis. Peripheral parasitaemia at delivery was detected in one (<1%) of 294 women in the intervention group and none of 308 women in the control group. The incidence of clinical malaria during pregnancy was lower in the intervention group than in the control group (one episode in the intervention group vs six in the control group; relative risk [RR] 0·12, 95% CI 0·03–0·52, p=0·045). In a post-hoc analysis, the composite outcome of overall malaria infection (detected by any diagnostic test during pregnancy or delivery) was lower in the intervention group than in the control group (14 [5%] of 311 women vs 31 [10%] of 320 women; RR 0·48, 95% CI 0·27–0·84, p=0·010). The frequency of serious adverse events and poor pregnancy outcomes (such as miscarriages, stillbirths, premature births, and congenital malformations) did not differ between groups. The most frequently reported drug-related adverse events were gastrointestinal disorder (reported in less than 4% of participants) and headache (reported in less than 2% of participants), with no differences between study groups. In the context of low malaria transmission, the addition of IPTp with dihydroartemisinin–piperaquine to co-trimoxazole prophylaxis in pregnant women with HIV did not reduce peripheral parasitaemia at delivery. However, the intervention was safe and associated with a decreased risk of clinical malaria and overall Plasmodium falciparum infection, so it should be considered as a strategy to protect pregnant women with HIV from malaria. European and Developing Countries Clinical Trials Partnership 2 (EDCTP2) and Medicines for Malaria Venture. For the Portuguese and French translations of the abstract see Supplementary Materials section.

Uncomplicated skin infections are a common outpatient clinical problem. In this randomized, controlled trial, clindamycin and trimethoprim–sulfamethoxazole (TMP-SMX) were compared as outpatient therapy for uncomplicated cellulitis or abscess. Skin and skin-structure infections (hereafter referred to as skin infections) are common conditions among patients seeking medical care in the United States, 1 , 2 accounting for approximately 14.2 million outpatient visits in 2005 1 and more than 850,000 hospital admissions. 3 Skin infections are associated with considerable complications, including bacteremia, the need for hospitalization and surgical procedures, and death. 4 , 5 Results of cultures of skin-infection lesions in the United States have shown that most of the infections are caused by methicillin-resistant Staphylococcus aureus (MRSA), 6 , 7 but the efficacy of various antibiotic regimens in areas where community-associated MRSA is endemic has not been defined. . . .

This study from four Australian centers examined whether low-dose, continuous oral antibiotic therapy would prevent urinary tract infection in children (under the age of 18 years) who had already had one or more microbiologically proven urinary tract infections. Long-term, low-dose trimethoprim–sulfamethoxazole was associated with a modest decrease in the number of urinary tract infections in predisposed children. Long-term, low-dose trimethoprim–sulfamethoxazole was associated with a modest decrease in the number of urinary tract infections in predisposed children. Urinary tract infection is a very common illness in children, affecting 2% of boys and 8% of girls by the age of 7 years. 1 Urinary tract infection is associated with long-term morbidity, with renal damage reported in about 5% of affected children. 2 The observation that urinary tract infection and vesicoureteral reflux are associated with renal damage 3 – 5 led to the standard clinical practice of assessment with voiding cystourethrography for the presence of vesicoureteral reflux in children who had had urinary tract infection 6 , 7 and the administration of daily low-dose antibiotics for many years 8 to prevent further urinary tract infections and . . .

In a double-blind, randomized, placebo-controlled trial in Zimbabwe, treatment of mothers with trimethoprim–sulfamethoxazole daily beginning as early as 14 weeks’ gestation did not significantly increase infant birth weight.

Background. Community-associated methicillin-resistant S. aureus (CA-MRSA) is the most common organism isolated from purulent skin infections. Antibiotics are usually not beneficial for skin abscess, and national guidelines do not recommend CA-MRSA coverage for cellulitis, except purulent cellulitis, which is uncommon. Despite this, antibiotics targeting CA-MRSA are prescribed commonly and increasingly for skin infections, perhaps due, in part, to lack of experimental evidence among cellulitis patients. We test the hypothesis that antibiotics targeting CA-MRSA are beneficial in the treatment of cellulitis. Methods. We performed a randomized, multicenter, double-blind, placebo-controlled trial from 2007 to 2011. We enrolled patients with cellulitis, no abscesses, symptoms for <1 week, and no diabetes, immunosuppression, peripheral vascular disease, or hospitalization (clinicaltrials.gov NCT00676130). All participants received cephalexin. Additionally, each was randomized to trimethoprim-sulfamethoxazole or placebo. We provided 14 days of antibiotics and instructed participants to continue therapy for ≥1 week, then stop 3 days after they felt the infection to be cured. Our main outcome measure was the risk difference for treatment success, determined in person at 2 weeks, with telephone and medical record confirmation at 1 month. Results. We enrolled 153 participants, and 146 had outcome data for intent-to-treat analysis. Median age was 29, range 3–74. Of intervention participants, 62/73 (85%) were cured versus 60/73 controls (82%), a risk difference of 2.7% (95% confidence interval, −9.3% to 15%; P = .66). No covariates predicted treatment response, including nasal MRSA colonization and purulence at enrollment. Conclusions. Among patients diagnosed with cellulitis without abscess, the addition of trimethoprim-sulfamethoxazole to cephalexin did not improve outcomes overall or by subgroup. Clinical Trials Registration. NCT00676130.

Background Sulfamethoxazole-trimethoprim (SMX/TMP) is a standard drug for the prophylaxis of Pneumocystis pneumonia (PJP) in immunosuppressed patients with systemic rheumatic diseases, but is sometimes discontinued due to adverse events (AEs). The objective of this non-blinded, randomized, 52-week non-inferiority trial was to quest an effective chemoprophylaxis regimen for PJP with a low drug discontinuation rate. Results at week 24 were reported. Methods Adult patients with systemic rheumatic diseases who started prednisolone ≥0.6 mg/kg/day were randomized into three dosage groups: a single-strength group (SS, SMX/TMP of 400/80 mg daily), half-strength group (HS, 200/40 mg daily), and escalation group (ES, started with 40/8 mg daily, increasing incrementally to 200/40 mg daily). The primary endpoint was non-incidence rates (non-IR) of PJP at week 24. Results Of 183 patients randomly allocated at a 1:1:1 ratio into the three groups, 58 patients in SS, 59 in HS, and 55 in ES started SMX/TMP. A total of 172 patients were included in the analysis. No cases of PJP were reported up to week 24. Estimated non-IR of PJP in patients who received daily SMX/TMP of 200/40 mg, either starting at this dose or increasing incrementally, was 96.8–100% using the exact confidence interval as a post-hoc analysis. The overall discontinuation rate was significantly lower with HS compared to SS ( p  = 0.007). The discontinuation rates due to AEs were significantly lower with HS ( p  = 0.006) and ES ( p  = 0.004) compared to SS. The IR of AEs requiring reduction in the dose of SMX/TMP ( p  = 0.009) and AEs of special interest ( p  = 0.003) were different among the three groups with significantly higher IR in SS compared to HS and ES. Conclusions Although there were no PJP cases, the combined group of HS and ES had an excellent estimated non-IR of PJP and both were superior in safety to SS. From the perspective of feasibility and drug discontinuation rates, the daily half-strength regimen was suggested to be optimal for prophylaxis of PJP in patients with systemic rheumatic diseases. Trial registration The University Hospital Medical Information Network Clinical Trials Registry number is UMIN000007727 , registered 10 April 2012.

Co-trimoxazole is effective in preventing opportunistic infections in persons with advanced HIV infection. In this trial in southern Africa, prolonged co-trimoxazole therapy (>96 weeks after initiation of ART) was shown to have continued benefit beyond CD4 T-cell recovery. Co-trimoxazole (fixed-dose trimethoprim–sulfamethoxazole) is commonly used in sub-Saharan Africa because of its low cost, wide availability, and broad-spectrum antimicrobial activity. Despite high levels of resistance to co-trimoxazole, prophylaxis with this drug combination before antiretroviral therapy (ART) reduces mortality, morbidity, and rates of hospitalization among human immunodeficiency virus (HIV)–infected adults 1 – 6 and children, 7 , 8 predominantly by reducing rates of pneumonia, diarrhea, and malaria. 1 – 8 The increasing availability of ART in sub-Saharan Africa has considerably reduced morbidity and mortality among HIV-infected children. 9 World Health Organization (WHO) guidelines 10 recommend daily co-trimoxazole prophylaxis for HIV-infected children younger than 2 years of age and for . . .

Objective: Systemic lupus erythematosus (SLE) patients receiving immunosuppressive therapy are at risk for opportunistic infections (OIs), particularly Pneumocystis pneumonia (PCP). This study aimed to evaluate the effectiveness of trimethoprim/sulfamethoxazole (TMP/SMX) as primary prophylaxis against OIs and its adverse effects in SLE patients receiving low-level immunosuppressive treatment in a real-world setting. Methods: This open-label randomized controlled trial enrolled SLE patients receiving low-level immunosuppressive treatment at Ramathibodi Hospital between May 2021 and December 2022. Patient demographics and relevant clinical data were collected. Participants were randomized 1:1 to receive TMP/SMX or no prophylaxis, with dose adjustments according to renal function. The incidences of TMP/SMX-sensitive OIs and adverse events were monitored for 12 months post-enrollment. Results : The trial was terminated early due to a high rate of adverse drug reactions (ADRs) associated with TMP/SMX. In total, 138 SLE patients receiving low-level immunosuppressive treatment were enrolled. Most patients (98.4%) were in disease remission. No TMP/SMX-sensitive OIs were observed in either group during the 12-month follow-up period. Among individuals receiving TMP/SMX, 10/70 (14.3%) developed ADRs. Of these 10 patients, eight experienced grade 1 ADRs, and two had grade 3 ADRs; all declined to resume prophylaxis. There were no deaths in the study. Conclusions : During the 12-month follow-up period, no TMP/SMX-sensitive OIs occurred in SLE patients receiving low-level immunosuppressive therapy, suggesting that primary prophylaxis with TMP/SMX may not significantly benefit this population. The high rate of ADRs observed underscores the need for clinicians to carefully consider the risks and benefits of TMP/SMX prophylaxis in these patients.