Post-exposure prophylaxis in leprosy (PEOPLE): a cluster randomised trial.

Background: Post-exposure prophylaxis (PEP) using single-dose rifampicin reduces progression from infection with Mycobacterium leprae to leprosy disease. We compared effectiveness of different administration modalities, using a higher (20 mg/kg) dose of rifampicin-single double-dose rifampicin (SDDR)-PEP.

Methods: We did a cluster randomised study in 16 villages in Madagascar and 48 villages in Comoros.

Hi-plex deep amplicon sequencing for identification, high-resolution genotyping and multidrug resistance prediction of Mycobacterium leprae directly from patient biopsies by using Deeplex Myc-Lep.

Background: Expansion of antimicrobial resistance monitoring and epidemiological surveillance are key components of the WHO strategy towards zero leprosy. The inability to grow Mycobacterium leprae in vitro precludes routine phenotypic drug susceptibility testing, and only limited molecular tests are available. We evaluated a culture-free targeted deep sequencing assay, for mycobacterial identification, genotyping based on 18 canonical SNPs and 11 core variable-number tandem-repeat (VNTR) markers, and detection of rifampicin, dapsone and fluoroquinolone resistance-associated mutations in rpoB/ctpC/ctpI, folP1, gyrA/gyrB, respectively, and hypermutation-associated mutations in nth.

Protocol, rationale and design of BE-PEOPLE (Bedaquiline enhanced exposure prophylaxis for LEprosy in the Comoros): a cluster randomized trial on effectiveness of rifampicin and bedaquiline as post-exposure prophylaxis of leprosy contacts.

Background: Leprosy is an ancient infectious disease with an annual global incidence of around 200,000 over the past decade. Since 2018, the World Health Organization (WHO) recommends single-dose rifampicin as post-exposure prophylaxis (SDR-PEP) for contacts of leprosy patients. The Post ExpOsure Prophylaxis for Leprosy (PEOPLE) trial evaluated PEP with a double dose of rifampicin in Comoros and Madagascar.

Pre-operative CT cephalometry and functional outcomes after open partial horizontal laryngectomy.

Objectives: To identify pre-operative radiological parameters that are able to predict the functional outcomes of open partial horizontal laryngectomy (OPHL).

Methods: The present retrospective study concerned a cohort of 96 patients with laryngeal squamous cell carcinoma who underwent pre-operative radiological staging with contrast-enhanced computerised tomography of the neck, and subsequent supracricoid or supratracheal laryngectomy. Univariate and multivariate analyses were run to assess the prognostic value of the main demographic and surgical variables, and the pre-operative cephalometric values, respectively, in terms of predicting patients' functional outcomes.

Minimally invasive sampling to identify leprosy patients with a high bacterial burden in the Union of the Comoros.

The World Health Organization (WHO) endorsed diagnosis of leprosy (also known as Hansen's disease) entirely based on clinical cardinal signs, without microbiological confirmation, which may lead to late or misdiagnosis. The use of slit skin smears is variable, but lacks sensitivity. In 2017-2018 during the ComLep study, on the island of Anjouan (Union of the Comoros; High priority country according to WHO, 310 patients were diagnosed with leprosy (paucibacillary = 159; multibacillary = 151), of whom 263 were sampled for a skin biopsy and fingerstick blood, and 260 for a minimally-invasive nasal swab.

Exploring clustering of leprosy in the Comoros and Madagascar: A geospatial analysis.

Objectives: To identify patterns of spatial clustering of leprosy.

Design: We performed a baseline survey for a trial on post-exposure prophylaxis for leprosy in Comoros and Madagascar. We screened 64 villages, door-to-door, and recorded results of screening, demographic data and geographic coordinates.

Protocol, rationale and design of PEOPLE (Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar): a cluster randomized trial on effectiveness of different modalities of implementation of post-exposure prophylaxis of leprosy contacts.

Background: Leprosy is an ancient infectious disease with a global annual incidence that has plateaued above 200,000 new cases since over a decade. New strategies are required to overcome this stalemate. Post-exposure prophylaxis (PEP) with a single dose of Rifampicin (SDR) has conditionally been recommended by the World Health Organization (WHO), based on a randomized-controlled-trial in Bangladesh.

Clustering of leprosy beyond the household level in a highly endemic setting on the Comoros, an observational study.

Background: The island of Anjouan (Comoros) is highly endemic for leprosy with an annual incidence of 5-10/10,000. In May/June, 2015 single-dose Rifampicin post-exposure prophylaxis (SDR-PEP) was administered to 269 close contacts of 70 leprosy-patients in four villages as a pilot programmatic intervention. Two years later we revisited the villages for follow-up investigations.

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

Objectives: The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology.

Methods: The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel.

Biventricular non-compaction demonstrated on multi-slice computed tomography with echocardiographic correlation.

Left ventricular non-compaction (LVNC) is a myocardial disorder characterized by prominent trabeculations and deep intertrabecular recesses within the left ventricular wall. Multi-slice computed tomography (CT) might represent a valid non-invasive imaging technique for the diagnostic work-up of these patients, being able to visualize the compacted and non-compacted layers and to simultaneously rule out the presence of associated coronary artery disease and congenital heart disease. In the present report, the CT features of LVNC are described.

Relapse rates and a 10-year follow-up of a 6-week quadruple drug regimen for multibacillary leprosy.

Between 1989 and 1993, 136 multibacillary leprosy patients received a 6-week treatment regimen consisting of daily rifampicin 600 mg, ofloxacin 400 mg, clofazimine 100 mg and a weekly dose of 100 mg minocycline. A previous analysis after a mean follow-up of 4-7 years revealed a relapse rate of 2%, involving six late (after more than 5 years of follow-up) relapses. During the following years, 12 more relapses appeared during years 8-9 of follow-up.

Detection of Mycobacterium leprae by the polymerase chain reaction in nasal swabs of leprosy patients and their contacts.

Nose swabs from 4 paucibacillary (PB) and 8 multibacillary (MB) leprosy patients and their contacts were tested for the presence of Mycobacterium leprae by two polymerase chain reactions (PCR); 30% of the samples contained inhibitors for the PCR, 1 of 52 (1.9%) swabs and 13 of 164 (7.9%) swabs were positive for M.

Leprosy in the Comores 1981-88.

The evolution of the leprosy endemic in the République Fédérale Islamique des Comores between 1981 and 1988 is described. Leprosy on Grande Comore seems to be extinct. On the island of Anjouan the yearly detection rate is 0.

Combined regimens of one year duration in the treatment of multibacillary leprosy--I. Combined regimens with rifampicin administered during one year.

In 1981, 1982 and 1983, 216 multibacillary patients in Anjouan (Comores) and Burundi were treated for 8 weeks with daily rifampicin (600 mg) ethionamide (500 mg) and dapsone (100 mg) or clofazimine (100 mg) followed for 44 weeks by once weekly rifampicin (600 mg) and daily ethionamide (500 mg) and dapsone (100 mg) or clofazimine (100 mg). There were 109 previously untreated patients and 107 patients who had dapsone monotherapy, 16 of whom were infected with proven dapsone resistant Mycobacterium leprae. Clinical and bacteriological results were excellent but hepatotoxicity of this regimen remains a problem.

The incubation time of relapses after treatment of multibacillary leprosy with rifampicin containing regimens.

In order to determine the duration of follow-up needed to evaluate the efficacy of short-course bactericidal regimens for multibacillary leprosy, information is needed on the incubation time of relapses after stopping treatment. Several groups of patients, who had been on rifampicin-containing regimens, were followed up for periods ranging from 4 to 10 years. Two groups of relapses were observed: early relapses occurring within 3.

[Inadequate treatment in multibacillary leprosy and incubation times for relapses].

Among a population of over 500 PB patients treated with different regimens, 6 multibacillary relapses were detected: 5 in patients erroneously classified as PB but in reality MB with a low bacterial load, one patient was PB at the start. Treatment regimens had been: 10 weekly doses of RMP either 600 mg (1 case) or 900 mg (1 case) two successive doses of RMP 1500 mg (1 case) a single dose of RMP 40 mg/K (3 cases). Four MB patients with proven DDS-R relapsed after a single dose of RMP either 20 mg/K (1 case) or 40 mg/K (3 cases).

[A new plan in the campaign against leprosy in Anjouan. Preliminary results].

Treatment of PB leprosy patients with 10 weekly doses of RMP 600 mg gave a cure rate of 88% or more at 3 years as judged by histopathology. There were no severe neurological complications. The future will show if this regimen also prevents relapses.

Hepatotoxicity of the combination of rifampin-ethionamide in the treatment of multibacillary leprosy.

During treatment of multibacillary leprosy with the combination rifampin (RMP) 600 mg, ethionamide (ETH) 500 mg, and either dapsone (DDS) or clofazimine (CLO) 100 mg, hepatotoxicity was observed in 4.5% of 596 patients. Hepatitis appeared after 5-186 days, with a mean of 93 days and a median of 76 days.