Ambulatory management of pre- and extensively drug resistant tuberculosis patients with imipenem delivered through port-a-cath: A mixed methods study on treatment outcomes and challenges

Chavan, Vijay; Dalal, Alpa; Nagaraja, Sharath Burugina; Thekkur, Pruthu; Mansoor, Homa; Meneguim, Augusto C; Paryani, Roma; Singh, Phirtu; Kalon, Stobdan; Das, Mrinalini; Ferlazzo, Gabriella; Isaakidis, Petros

doi:10.1371/journal.pone.0234651

Cited by 12 publications

(10 citation statements)

References 16 publications

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“…Another study also reported resistance to the SLD as a key predictor of poor outcome (OR: 2.61; 95% CI: 1.61-4.21) [81]. Besides, a 31.4% incidence proportion of mortality was reported among the cohort of patients with any form of resistance to SLD therapy [99]. This mortality could reach more than 50% among under-treated patients with the resistant strains [100].…”

Section: Plos Onementioning

confidence: 98%

Incidence and predictors of mortality among persons receiving second-line tuberculosis treatment in sub-Saharan Africa: A meta-analysis of 43 cohort studies

et al. 2021

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Background Drug resistance remains from among the most feared public health threats that commonly challenges tuberculosis treatment success. Since 2010, there have been rapid evolution and advances to second-line anti-tuberculosis treatments (SLD). However, evidence on impacts of these advances on incidence of mortality are scarce and conflicting. Estimating the number of people died from any cause during the follow-up period of SLD as the incidence proportion of all-cause mortality is the most informative way of appraising the drug-resistant tuberculosis treatment outcome. We thus aimed to estimate the pooled incidence of mortality and its predictors among persons receiving the SLD in sub-Saharan Africa. Methods We systematically identified relevant studies published between January, 2010 and March, 2020, by searching PubMed/MEDLINE, EMBASE, SCOPUS, Cochrane library, Google scholar, and Health Technology Assessment. Eligible English-language publications reported on death and/or its predictors among persons receiving SLD, but those publications that reported death among persons treated for extensively drug-resistant tuberculosis were excluded. Study features, patients’ clinical characteristics, and incidence and/or predictors of mortality were extracted and pooled for effect sizes employing a random-effects model. The pooled incidence of mortality was estimated as percentage rate while risks of the individual predictors were appraised based on their independent associations with the mortality outcome. Results A total of 43 studies were reviewed that revealed 31,525 patients and 4,976 deaths. The pooled incidence of mortality was 17% (95% CI: 15%-18%; I2 = 91.40; P = 0.00). The studies used varied models in identifying predictors of mortality. They found diagnoses of clinical conditions (RR: 2.36; 95% CI: 1.82–3.05); excessive substance use (RR: 2.56; 95% CI: 1.78–3.67); HIV and other comorbidities (RR: 1.96; 95% CI: 1.65–2.32); resistance to SLD (RR: 1.75; 95% CI: 1.37–2.23); and male sex (RR: 1.82; 95% CI: 1.35–2.44) as consistent predictors of the mortality. Few individual studies also reported an increased incidence of mortality among persons initiated with the SLD after a month delay (RR: 1.59; 95% CI: 0.98–2.60) and those persons with history of tuberculosis (RR: 1.21; 95% CI: 1.12–1.32). Conclusions We found about one in six persons who received SLD in sub-Saharan Africa had died in the last decade. This incidence of mortality among the drug-resistant tuberculosis patients in the sub-Saharan Africa mirrors the global average. Nevertheless, it was considerably high among the patients who had comorbidities; who were diagnosed with other clinical conditions; who had resistance to SLD; who were males and substance users. Therefore, modified measures involving shorter SLD regimens fortified with newer or repurposed drugs, differentiated care approaches, and support of substance use rehabilitation programs can help improve the treatment outcome of persons with the drug-resistant tuberculosis. Trial registration number CRD42020160473; PROSPERO

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Section: Plos Onementioning

confidence: 98%

Incidence and predictors of mortality among persons receiving second-line tuberculosis treatment in sub-Saharan Africa: A meta-analysis of 43 cohort studies

et al. 2021

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“…Similar studies have documented only sputum culture conversion rates of up to 72%. 11,15 Our study serves to prove that treatment of pediatric MDRFQ/SLI/XDR-TB using meropenem via home-based intravenous therapy is feasible even in resource constrained areas. It also shows that the newer antitubercular drugs, Dlm and Bdq may be promising therapeutic options even in the pediatric population especially for those with limited drug alternatives available.…”

Section: Discussionmentioning

confidence: 91%

“…9,10 Attempts at implementing an ambulatory home-based Imipenem therapy through a port-a-cath have been made in the recent past and appear to be promising although several practical hurdles may have to be tackled. 11 We present the findings of our study on feasibility of a "salvage regimen" using home-based carbapenem therapy through peripherally inserted central catheter (PICC) as part of a longer (18-20 months) optimized background regimen (OBR) including Dlm/Bdq/both in pediatric MDR FQ/SLI /XDR-TB patients.…”

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Feasibility of a “Salvage Regimen” Using Home-based Intravenous Meropenem Therapy With a Delamanid/Bedaquilline Containing Regimen in the Management of MDR/XDR Pediatric Tuberculosis

Shah

Antony

Jaiswal

et al. 2022

Pediatric Infectious Disease Journal

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Introduction:The prevalence of multidrug resistant (MDR) tuberculosis (TB) with additional resistance to fluoroquinolones or second-line injectables (MDR FQ/SLI )/extensively drug-resistant TB (XDR-TB) in children is high in Mumbai. There are limited therapeutic options available in management of such children. Carbapenems, although approved for this indication, requires 2 to 3 daily injections, which are cumbersome. Bedaquilline (Bdq) and Delamanid (Dlm), the new antitubercular drugs still remain inaccessible to this subset of patients caused by conditional approvals. Hence, newer strategies to combat MDR FQ/SLI /XDR-TB needs to be explored. Objectives: To study feasibility and interim outcomes of a "salvage regimen" using home-based carbapenem therapy through peripherally inserted central catheter as part of a longer (18-20 months) optimized background regimen including Dlm or Bdq or both in pediatric MDR FQ/SLI /XDR-TB patients who failed a standard MDR-TB regimen under the National Tuberculosis Elimination Programme in Mumbai, India. Design and Methods: Retrospective descriptive analysis study. National Tuberculosis Elimination Programme medical records of all MDR FQ/SLI / XDR-TB patients enrolled at the pediatric TB clinic at BJ Wadia Hospital for Children, Mumbai who were initiated on such "salvage regimen" during the period between April 2018 and December 2020 were retrospectively studied. Treatment outcomes and adverse events were described. Results: Of the 15 patients enrolled, mean age of the patient population was 12.53 ± 2.47 years and the female:male ratio was 13:2. Seven patients had XDR-TB while 8 patients had MDR FQ/SLI . Most common adverse event noted was dyselectrolytemia (3 patients). Catheter-related complications were reported in 5 patients and included catheter blockage, leak, and thrombosis. Sputum culture conversion was reported in all of the patients. One child mortality was reported and 2 patients were lost to follow up during study period. Conclusions: Home-based meropenem therapy using peripherally inserted central catheter is feasible with few adverse effects. This can be a promising strategy in the management of MDR FQ/SLI /XDR-TB when an effective oral regimen cannot be otherwise constituted and needs to be explored further.

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“…Из 70 пациентов (72,9% -ШЛУ-ТБ), благоприятные исходы были у 61,4% пациентов, смертность -у 31,4%, пациентов, и 4,3% были признаны неэффективными. Хотя результаты амбулаторных схем, содержащих имипенем, были многообещающими, всё-таки при оказании помощи было несколько проблем, связанных с ограниченной мобильностью из-за катетеризации, недостатка инфекционного контроля и места в доме пациентов для оптимального ухода [48].…”

Section: применение бета-лактамов для лечения больных туберкулёзомunclassified

Beta-lactam antibiotics as reserve medications for the treatment of drug-resistant tuberculosis

Можокина¹,

Samoilova²,

Vasilyeva³

2021

A&Ch

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The review article presents an analysis of literature data on the necessity to expand the range of medications possessing anti-tuberculosis activity for the treatment of the most severe forms of drug-resistant tuberculosis through the use of beta-lactam antibiotics in chemotherapy regimens. The mechanism of action of beta- lactam antibiotics on mycobacterium tuberculosis is shown, and the results of in vitro studies to assess their anti-tuberculosis activity are presented. Clinical studies on the use of carbapenems prove the feasibility of their use for the treatment of patients with tuberculosis with multiple and extensive drug resistance of the pathogen.

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Ambulatory management of pre- and extensively drug resistant tuberculosis patients with imipenem delivered through port-a-cath: A mixed methods study on treatment outcomes and challenges

Cited by 12 publications

References 16 publications

Incidence and predictors of mortality among persons receiving second-line tuberculosis treatment in sub-Saharan Africa: A meta-analysis of 43 cohort studies

Incidence and predictors of mortality among persons receiving second-line tuberculosis treatment in sub-Saharan Africa: A meta-analysis of 43 cohort studies

Feasibility of a “Salvage Regimen” Using Home-based Intravenous Meropenem Therapy With a Delamanid/Bedaquilline Containing Regimen in the Management of MDR/XDR Pediatric Tuberculosis

Beta-lactam antibiotics as reserve medications for the treatment of drug-resistant tuberculosis

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