Background: There is global concern regarding the spread of antimicrobial resistance in bacteria and fungi. Oncology patients are at particular risk of infections with multidrug resistant organisms. These patients require urgent initiation of empiric antimicrobial therapy when presenting with neutropenic fever. Currently, piperacillin-tazobactam and amikacin with or without vancomycin is the treatment of choice in the unit.Aim: The purpose of this study was to develop a cumulative antibiogram for the paediatric oncology unit at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) to guide empiric treatment recommendations for patients presenting with suspected bacterial or fungal infection.Setting: Tertiary-level paediatric oncology unit.Methods: A retrospective observational analysis was performed of bacterial and fungal antimicrobial susceptibility data extracted from the microbiology laboratory information system for clinical specimens submitted from the paediatric oncology unit at CMJAH. Data was analysed for the period January 2015 to May 2018. In addition, analysis and comparison of two 17-month time periods was performed in order to elicit any changes over time.Results: Klebsiella pneumoniae and Escherichia coli were the most common gram-negative organisms isolated. Twenty-one percent of Enterobacteriaceae showed resistance to third generation cephalosporins and 9% to carbapenems. Rates of carbapenem-resistant isolates decreased significantly over time. Adding amikacin to piperacillin-tazobactam significantly increased bacterial coverage. Coagulase-negative staphylococci and Candida parapsilosis were the most common gram-positive and fungal isolates recovered during the study.Conclusion: The results support the continued use of piperacillin-tazobactam and amikacin for paediatric oncology patients presenting with neutropenic fever in this unit. Antibiograms are an important component of antimicrobial stewardship in conjunction with efficient infection prevention and control measures.
BackgroundQuality control (QC) and evaluation of HIV rapid test procedures are an important aspect of HIV prevention trials. We describe QC and performance of two rapid tests, Determine™ and Uni-Gold™ used in a microbicide clinical trial in rural KwaZulu-Natal, South Africa.Methods/ResultsInternal QC of both HIV rapid tests was conducted at the trial site using a Uni-Gold control kit (Uni-Gold™Recombigen® HIV). Both assays produced the expected results for a total of 4637 QC tests. Study participants were tested for HIV at screening and, if enrolled, at regular time points throughout the study. Positive or discordant results were confirmed by a double HIV immunoassay testing strategy at a local laboratory. Overall, 15292 HIV rapid test were performed. Sensitivity and specificity of Determine was 98.95% (95% CI: 97.72–99.61) and 99.83% (95% CI: 99.70–99.91) respectively [positive predictive value (PPV) 97.91% (95% CI: 96.38–98.92)], for Uni-Gold it was 99.30% (95% CI: 98.21–99.81) and 99.96% (95% CI: 99.88–99.99) respectively [PPV 99.47% (95% CI: 98.46–99.89)].ConclusionsThe results suggest that a Uni-Gold control kit can be used for internal QC of both Uni-Gold and the HIV-1 component of the Determine rapid tests. Both rapid tests performed proficiently in the trial population.
Background The World Health Organization (WHO) recommends systematic symptom screening for tuberculosis (TB). However, TB prevalence surveys suggest that this strategy does not identify millions of TB patients, globally. Undiagnosed or delayed diagnosis of TB contribute to TB transmission and exacerbate morbidity and mortality. We conducted a cluster-randomized trial of large urban and rural primary healthcare clinics in 3 provinces of South Africa to evaluate whether a novel intervention of targeted universal testing for TB (TUTT) in high-risk groups diagnosed more patients with TB per month compared to current standard of care (SoC) symptom-directed TB testing. Methods and findings Sixty-two clinics were randomized; with initiation of the intervention clinics over 6 months from March 2019. The study was prematurely stopped in March 2020 due to clinics restricting access to patients, and then a week later due to the Coronavirus Disease 2019 (COVID-19) national lockdown; by then, we had accrued a similar number of TB diagnoses to that of the power estimates and permanently stopped the trial. In intervention clinics, attendees living with HIV, those self-reporting a recent close contact with TB, or a prior episode of TB were all offered a sputum test for TB, irrespective of whether they reported symptoms of TB. We analyzed data abstracted from the national public sector laboratory database using Poisson regression models and compared the mean number of TB patients diagnosed per clinic per month between the study arms. Intervention clinics diagnosed 6,777 patients with TB, 20.7 patients with TB per clinic month (95% CI 16.7, 24.8) versus 6,750, 18.8 patients with TB per clinic month (95% CI 15.3, 22.2) in control clinics during study months. A direct comparison, adjusting for province and clinic TB case volume strata, did not show a significant difference in the number of TB cases between the 2 arms, incidence rate ratio (IRR) 1.14 (95% CI 0.94, 1.38, p = 0.46). However, prespecified difference-in-differences analyses showed that while the rate of TB diagnoses in control clinics decreased over time, intervention clinics had a 17% relative increase in TB patients diagnosed per month compared to the prior year, interaction IRR 1.17 (95% CI 1.14, 1.19, p < 0.001). Trial limitations were the premature stop due to COVID-19 lockdowns and the absence of between-arm comparisons of initiation and outcomes of TB treatment in those diagnosed with TB. Conclusions Our trial suggests that the implementation of TUTT in these 3 groups at extreme risk of TB identified more TB patients than SoC and could assist in reducing undiagnosed TB patients in settings of high TB prevalence. Trial registration South African National Clinical Trials Registry DOH-27-092021-4901.
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