Scabies is a dermatological parasitic infestation prevalent in many regions worldwide. Classified as a neglected disease by World Health Organization (WHO) since 2017, it is often associated with poor living conditions and overcrowding. Towards the end of 2021, unusual high numbers of scabies cases in outpatient consultations were observed in two Médecins Sans Frontières’ (MSF) Primary Healthcare Centers (PHCs) in Rohingya refugee camps in Cox’s Bazar, Bangladesh. Here, we aimed to describe the epidemiological and clinical characteristics of patients with scabies consulting the clinics from July 2022–November 2023. A cross-sectional study using routinely collected data from scabies’ consultations at two MSF clinics located in camp 14 and 15 (total population 91,241 in 2023) was conducted. We retrospectively analyzed programmatic data of patients of all ages attending outpatient consultations and clinically diagnosed as scabies. Data were extracted from MSF clinical routine monitoring databases and descriptive statistics were reported. During the 16-month period, a total of 178,922 scabies consultations were recorded, amongst whom 57.7% were women and 42.3% men. Children <5 years constituted 20.5% of the cases, age-groups 6-14, 36.6%, and ≥15 years, 42.9%. Camp 15 had the highest number of cases (39.4%), followed by other camps (29.7%), and then camp 14 (24.4%). Most cases were simple scabies (79.5%); one in five were scabies with secondary infection cases. Patients were mainly treated with oral ivermectin (71.2%) and topical permethrin (24.3%); 19.5% of patients also received antibiotics. Our findings indicate that scabies is a significant health concern in the Cox’s Bazar refugee camp. This study recorded over 178000 cases in the above period. The scale of this outbreak warrants further actions, including a prevalence survey, quality implementation of mass drug administration, and multidisciplinary interventions related to camps’ living conditions such as water and sanitation.
BACKGROUND
The 2022 WHO guidelines on multi-drug/rifampicin resistant tuberculosis (MDR/RR-TB) recommend six months of bedaquiline (Bdq) in the all-oral 9-month shorter regimen and six months or longer for Bdq and delamanid (Dlm) in the 18-20-month longer regimen. However, lack of evidence on extended treatment using Bdq or Dlm has limited their use to six months. We examine the frequency and incidence of QT prolongation based on duration of Bdq and/or Dlm use in longer regimens.
METHODS
We analyzed a prospective cohort of MDR/RR-TB patients from 16 countries who initiated treatment with Bdq and/or Dlm containing regimens from 1 April 2015-30 September 2018. Data were systematically collected using a shared protocol. The outcome of interest was the first clinically relevant prolonged QT interval (grade 3 or above) or a Serious Adverse Event (SAE) involving prolonged QT of any grade.
RESULTS
Among 2,553 patients, 59% received >6 months of Bdq and/or Dlm. Of these, 579 (20.9%) patients experienced a prolonged QT event, the majority (95.5%) being grade 1 or 2. Sixty-four(2.5%) patients experienced the outcome of interest with only 12 (0.5%) having ≥ 1 QT prolonging drugs permanently suspended. The incidence rate of the first prolonged QT event was highest in the first six months of treatment and lower in subsequent six-month periods.
CONCLUSION
We demonstrate that Bdq and/or Dlm use beyond six months is safe in longer MDR/RR-TB regimens with most clinically relevant QT prolongation events occurring in the first six months. ECG monitoring for early identification of QT prolongating events is possible in programmatic conditions.
Addressing occupational injury and disease has been declared a national priority in Bangladesh. However critical gaps remain in improving work safety in small-scale peri-urban factories. We aimed to assess the feasibility of collaborating with owners and workers to design and implement interventions to improve work safety in two metal factories in Kamrangirchar, Dhaka.
METHODS
We implemented a participatory mixed methods before-and-after study with four phases. Phase 1 explored the dynamics of injuries, hazards, and risks using hazard assessments, surveillance, in-depth interviews, and focus group discussions. Triangulation of phase 1 findings informed design and implementation of intervention packages implemented in phase 2. In phases 3 and 4, we repeated hazard assessments and used qualitative methods to document changes in hazards and perspectives at 6- and 12-months post-intervention. Observations captured by field notes complemented data generated throughout the study.
ETHICS
The study was approved by the MSF Ethical Review Board (ERB) and by the ERB of the Centre for Injury Prevention and Research, Bangladesh.
RESULTS
Overall 136 workers in two factories (A and B) participated in the study (with a turnover of 41.5%). Surveillance captured 129 injuries during phase 1 (from 10th March 2019 in factory A and 30th April 2019 in factory B, to 31st July 2019), and all workers aged under 18 years experienced incidents. Hazard assessments documented hazard risk scores (HRS) of 54% in factory A and 36% in factory B. Qualitative data indicated workers perceived their work as risky, but explained it was prioritised over their health due to financial necessity. Phase 2 intervention packages included engineering controls, personal protective equipment, infrastructure safety and training. Factory owners and workers actively participated in design and implementation. Phase 3 showed a two-fold reduction in HRS in factory A (24%) and a 1.5-fold reduction (21%) in factory B. Phase 4 hazard assessment revealed that improvement was sustained in one factory; the final HRS was 27% in factory A, but returned to the pre-intervention score of 36% in factory B. Workers explained they observed improvements in workplace safety but noted challenges in sustainability due to owner commitment and worker turnover. Observation and qualitative data revealed complex power dynamics in the factories, as well as power imbalances and risks faced by female and young workers.
CONCLUSION
It was feasible to collaborate with workers and owners to implement interventions aimed at improving work safety. However, sustainability was mixed, and long-standing structural inequities that contribute to poor safety remain. Findings indicate urgent action is needed to improve safety and build an inclusive model of occupational health, including social and protection components, with particular attention for female workers and workers aged under 18.
CONFLICTS OF INTEREST
None declared
Concomitant use of bedaquiline (Bdq) and delamanid (Dlm) for multi-drug/rifampicin resistant tuberculosis (MDR/RR-TB) has raised concerns about a potentially poor risk-benefit ratio. Yet, this combination is an important alternative for patients infected with strains of TB with complex drug resistance profiles or who cannot tolerate other therapies. We assessed safety and treatment outcomes of MDR/RR-TB patients receiving concomitant Bdq and Dlm, along with other second-line anti-TB drugs.
METHODS
We conducted a multi-centric, prospective observational cohort study across 14 countries among patients receiving concomitant Bdq-Dlm treatment. Patients were recruited between April 2015 and September 2018 and were followed until the end of treatment. All serious adverse events and adverse events of special interest (AESI), leading to a treatment change, or judged significant by a clinician, were systematically monitored and documented.
RESULTS
Overall, 472 patients received Bdq and Dlm concomitantly. A large majority also received linezolid (89.6%) and clofazimine (84.5%). Nearly all (90.3%) had extensive disease; most (74.2%) had resistance to fluoroquinolones. The most common AESI were peripheral neuropathy (134, 28.4%) and electrolyte depletion (94, 19.9%). Acute kidney injury and myelosuppression were seen in 40 (8.5%) and 24 (5.1%) of patients, respectively. QT prolongation occurred in 7 (1.5%). Overall, 78.0% (358/458) had successful treatment outcomes, 8.9% died and 7.2% experienced treatment failure.
CONCLUSIONS
Concomitant use of Bdq and Dlm, along with linezolid and clofazimine, is safe and effective for MDR/RR-TB patients with extensive disease. Using these drugs concomitantly is a good therapeutic option for patients with resistance to many anti-TB drugs.
Safety of treatment for multidrug-resistant tuberculosis (MDR/RR-TB) can be an obstacle to treatment completion.
OBJECTIVES
Evaluate safety of longer MDR/RR-TB regimens containing bedaquiline and/or delamanid.
METHODS
Multicentre (16 countries), prospective, observational study, reporting incidence and frequency of clinically relevant adverse events of special interest (AESI) amongst patients who received MDR/RR-TB treatment containing bedaquiline and/or delamanid. The AESIs were defined a priori as important events caused by bedaquiline, delamanid, linezolid, injectables, and other commonly used drugs. Occurrence of these events was also reported by exposure to the likely causative agent.
RESULTS
Among 2296 patients, the most common clinically relevant AESIs were: peripheral neuropathy in 26.4%, electrolyte depletion in 26.0%, and hearing loss in 13.2% of patients. Per 1000 person-months of treatment, the incidence of these events was 21.5 (95% confidence interval [CI]: 19.8-23.2), 20.7 (95% CI: 19.1-22.4), and 9.7 (95% CI: 8.6-10.8), respectively. QT interval was prolonged in 2.7% or 1.8 (95% CI: 1.4-2.3)/1000 person-months of treatment. Patients who received injectables (N=925) and linezolid (N=1826) were most likely to experience events during exposure: Hearing loss, acute renal failure, or electrolyte depletion occurred in 36.8% or 72.8 (95%CI: 66.0-80.0) times/1000 person-months of injectable drug exposure. Peripheral neuropathy, optic neuritis and/or myelosuppression occurred in 27.8% or 22.8 (95% CI: 20.9-24.8) times/1000 patient-months of linezolid exposure.
CONCLUSIONS
Adverse events often related to linezolid and injectable drugs were more common than those frequently attributed to bedaquiline and delamanid. MDR-TB treatment monitoring schedules and individual drug durations should reflect expected safety profiles of drug combinations.
CLINICAL TRIALS REGISTRATION
NCT02754765
Delamanid should be effective against highly resistant strains of Mycobacteriumtuberculosis, but uptake has been slow globally. In the endTB (expand new drug markets for TB) Observational Study, which enrolled a large, heterogeneous cohorts of patients receiving delamanid as part of a multidrug regimen, 80% of participants experienced sputum culture conversion within 6 months.