In an Indian oncology setting, between August and December 2021, 56 patients, developed Burkholderia cenocepacia bacteremia. An investigation revealed a contaminated batch of the antiemetic drug palonosetron. The outbreak was terminated by withdrawing the culprit batch and the findings were reported promptly to regulatory authorities.
An abstract is not available for this content so a preview has been provided. As you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Purpose: Patients receiving colistin for carbapenem-resistant gram-negative bacteria (CR-GNB) infections generally have multiple risk factors for nephrotoxicity, so it might be possible that colistin may be erroneously blamed for the nephrotoxicity. Materials and methods: We retrospectively analyzed case records of patients who received colistin and those who received antibiotics other than colistin [carbapenem or beta-lactam-beta-lactamases inhibitors (beta L-beta LI)] for gram-negative bacteremia. Those patients with preexisting renal failure and those who received antibiotics for <72 hours were excluded from the study. Nephrotoxicity was assessed using the risk of renal dysfunction, injury to the kidney, failure of kidney function, loss of kidney function, end-stage kidney disease (RIFLE) criteria. Results:Out of the 222 patients, the colistin arm had 118 and the noncolistin arm had 104 patients. Even though the coiistin arm had significantly higher number of sicker patients with neutropenia (40.7% vs 14.4%, p = 0.0001), mechanical ventilation (0.0001), having lines (0.0001), on inotropes (0.003), receiving other nephrotoxic drugs (0.0001), and higher Pitt score (p = 0.0001), there was no significant difference in the nephrotoxicity between the two arms (10.2% vs 9.6%, p = 0.89). Logistical regression showed a higher Pitt bacteremia score (p = 0.03) and a higher Charison comorbidity index (p = 0.02), but not coiistin administration (p = 0.32), were independently associated with nephrotoxicity. Conclusion: Administration of coiistin was not associated with higher rates of nephrotoxicity than carbapenems or beta L-beta LI agents.
CONTEXT:Limited Indian data are available on the rate of colistin nephrotoxicity and other risk factors contributing to the development of this important side effect.AIM:This study aims to generate data on colistin nephrotoxicity from a large cohort of Indian patients.DESIGN:Retrospective cohort study.MATERIALS AND METHODS:Case record analysis of patients who received colistin, in an oncology center in India, between January 2011 and December 2015. Nephrotoxicity was assessed using risk, injury, failure, loss, and end-stage (RIFLE) criteria.STATISTICAL ANALYSIS:P < 0.05 was considered as statistically significant.RESULTS:Out of the 229 patients, 13.1% (30/229) developed abnormal RIFLE. Abnormal RIFLE group (n = 30), in comparison to the normal renal function group (n = 199), had higher number of patients in intensive care unit (ICU) (96% vs. 79%, P = 0.02), higher Acute Physiology and Chronic Health Evaluation (APACHE II) score (23 vs. 19 P = 0.0001), Charlson score (5.9 vs. 4.3, P = 0.001), mechanical ventilation (90% vs. 67%, P = 0.016), 28 days mortality (63% vs. 25%, P = 0.0001), and abnormal baseline creatinine (36% vs. 8%, P = 0.001). Coadministration of vancomycin had higher rates of nephrotoxicity (P = 0.039). There was no significant difference in nephrotoxicity between 6 and 9 MU/day dosing pattern (8.8% vs. 13.8%, P = 0.058).CONCLUSION:Nephrotoxicity rate in our retrospective single center large series of patients receiving colistin was 13.1%. Patients with abnormal baseline creatinine, ICU stay, and higher disease severity are at higher risk of nephrotoxicity while on colistin. A daily dose of 9 million does not significantly increase nephrotoxicity compared to the 6 million. Concomitant administration of vancomycin with colistin increases the risk of nephrotoxicity.
BACKGROUND:Colistin-based combination therapy (CCT) is extensively used to treat infections due to carbapenem-resistant Gram-negative bacteria (CRGNB). There are no data available from India on the usefulness of combination therapy, especially in the oncology setup. The aim of this study was to analyze the clinical effectiveness of CCT over monotherapy in patients with CRGNB. MATERIALS AND METHODS:We conducted a retrospective, observational study of patients with CRGNB bloodstream infections in our oncology and bone marrow transplant center. RESULTS:Over a 3-year study period (2011-2014), we could identify 91 patients satisfying study criteria. There was no statistically significant difference in the 28-day mortality between monotherapy and combination therapy arms (mono n = 26, mortality 10 (38.5%); combination n = 65, mortality 28 (40%); P = 0.886). Neutropenic patients with Enterobacteriaceae bloodstream infections performed better with combination therapy (mono n = 7, mortality 6 (85.7%); combination therapy n = 22, mortality 8 (36.4%); P = 0.035). There was no significant difference in the 28-day mortality between the two treatment arms in other subgroups. CONCLUSION:Our study did not find CCT superior to colistin monotherapy in patients with CRGNB blood stream infections; except in the subgroup of neutropenic patients with Enterobacteriaceae bloodstream infections, where combination therapy performed better.
Objective:The aim was to fi nd the incidence of acute encephalitis syndrome (AES) secondary to scrub infection and to observe the clinical, biochemical, radiological profi le, and outcomes in these patients.Materials and Methods: A total of 20 consecutive patients of AES were evaluated for scrub infection using scrub typhus immunoglobulin M enzyme linked immuno-sorbant assay positivity along with the presence or absence of an eschar.Clinical profi le, routine laboratory tests, cerebrospinal fl uid (CSF) analysis, and neuroimaging were analyzed.Patients were treated with doxycycline and followed-up.Results: Among 20 consecutive patients with AES, 6 (30%) were due to scrub infection.They presented with acute onset fever, altered sensorium, seizures."Eschar" was seen in 50% of patients.CSF done in two of them was similar to consistent with viral meningitis.Magnetic resonance imaging brain revealed cerebral edema, bright lesions in the putamen and the thalamus on T2-weighted and fl uid-attenuated inversion recovery sequences.Renal involvement was seen in all patients.All patients responded well to oral doxycycline.Conclusion: AES is not an uncommon neurological presentation following scrub typhus infection.It should be suspected in all patients with fever, altered sensorium, and renal involvement.Oral doxycycline should be started as early as possible for better outcomes.