Seção de Ensino

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Navegando Seção de Ensino por Autor "Adjobimey, M."

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    Four Months of Rifampin or Nine Months of Isoniazid for Latent Tuberculosis in Adults
    (The New England Journal of Medicine, 2018) Menzies, D.; Adjobimey, M.; Ruslami, R.; Trajman, A.; Sow, O.; Kim, H.; Baah, J. Obeng; Marks, G.B.; Long, R.; Hoeppner, V.; Elwood, K.; Al‐Jahdali, H.; Gninafon, M.; Apriani, L.; Koesoemadinata, R.C.; Kritski, A.; Rolla, V.; Bah, B.; Camara, A.; Boakye, I.; Cook, V.J.; Goldberg, H.; Valiquette, C.; K. Hornby; Dion, M.-J.; Li, P.-Z.; Hill, P.C.; Schwartzman, K.; Benedetti, A.
    BACKGROUND: A 9-month regimen of isoniazid can prevent active tuberculosis in persons with latent tuberculosis infection. However, the regimen has been associated with poor adherence rates and with toxic effects. METHODS: In an open-label trial conducted in nine countries, we randomly assigned adults with latent tuberculosis infection to receive treatment with a 4-month regimen of rifampin or a 9-month regimen of isoniazid for the prevention of confirmed active tuberculosis within 28 months after randomization. Noninferiority and potential superiority were assessed. Secondary outcomes included clinically diagnosed active tuberculosis, adverse events of grades 3 to 5, and completion of the treatment regimen. Outcomes were adju- dicated by independent review panels. RESULTS: Among the 3443 patients in the rifampin group, confirmed active tuberculosis developed in 4 and clinically diagnosed active tuberculosis developed in 4 during 7732 person-years of follow-up, as compared with 4 and 5 patients, respectively, among 3416 patients in the isoniazid group during 7652 person-years of follow-up. The rate differences (rifampin minus isoniazid) were less than 0.01 cases per 100 person-years (95% confidence inter- val [CI], −0.14 to 0.16) for confirmed active tuberculosis and less than 0.01 cases per 100 person-years (95% CI, −0.23 to 0.22) for confirmed or clinically diagnosed tuberculosis. The upper boundaries of the 95% confidence interval for the rate differences of the confirmed cases and for the confirmed or clinically diagnosed cases of tuberculosis were less than the prespecified noninferiority margin of 0.75 percentage points in cu- mulative incidence; the rifampin regimen was not superior to the isoniazid regimen. The difference in the treatment-completion rates was 15.1 percentage points (95% CI, 12.7 to 17.4). The rate differences for adverse events of grade 3 to 5 occurring within 146 days (120% of the 4-month planned duration of the rifampin regimen) were −1.1 percentage points (95% CI, −1.9 to −0.4) for all events and −1.2 percentage points (95% CI, −1.7 to −0.7) for hepatotoxic events. CONCLUSIONS: The 4-month regimen of rifampin was not inferior to the 9-month regimen of isoniazid for the prevention of active tuberculosis and was associated with a higher rate of treat- ment completion and better safety. (Funded by the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council; ClinicalTrials.gov number, NCT00931736.).
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    Resource implications of the latent tuberculosis cascade of care: a time and motion study in five countries
    (BMC Health Services Research, 2020) Alsdurf, H.; Oxlade, O.; Adjobimey, M.; Ahmad Khan, F.; Bastos, M.; Bedingfield, N.; Benedetti, A.; Boafo, D.; Buu, T. N.; Chiang, L.; Cook, V.; Fisher, D.; Fox, G. J.; Fregonese, F.; Hadisoemarto, P.; Johnston, J. C.; Kassa, F.; Long, R.; Moayedi Nia, S.; Nguyen, T. A.; Obeng, J.; Paulsen, C.; Romanowski, K.; Ruslami, R.; Schwartzman, K.; Sohn, H.; Strumpf, E.; Trajman, A.; Valiquette, C.; Yaha, L.; Menzies, D.
    Background: The End TB Strategy calls for global scale-up of preventive treatment for latent tuberculosis infection (LTBI), but little information is available about the associated human resource requirements. Our study aimed to quantify the healthcare worker (HCW) time needed to perform the tasks associated with each step along the LTBI cascade of care for household contacts of TB patients. Methods: We conducted a time and motion (TAM) study between January 2018 and March 2019, in which consenting HCWs were observed throughout a typical workday. The precise time spent was recorded in pre- specified categories of work activities for each step along the cascade. A linear mixed model was fit to estimate the time at each step. Results: A total of 173 HCWs in Benin, Canada, Ghana, Indonesia, and Vietnam participated. The greatest amount of time was spent for the medical evaluation (median: 11 min; IQR: 6–16), while the least time was spent on reading a tuberculin skin test (TST) (median: 4 min; IQR: 2–9). The greatest variability was seen in the time spent for each medical evaluation, while TST placement and reading showed the least variability. The total time required to complete all steps along the LTBI cascade, from identification of household contacts (HHC) through to treatment initiation ranged from 1.8 h per index TB patient in Vietnam to 5.2 h in Ghana. Conclusions: Our findings suggest that the time requirements are very modest to perform each step in the latent TB cascade of care, but to achieve full identification and management of all household contacts will require additional human resources in many settings.
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    Safety and Side Effects of Rifampin versus Isoniazid in Children
    (New England Journal of Medicine, 2018) Diallo, T.; Adjobimey, M.; Ruslami, R.; Trajman, A.; Sow, O.; Baah, J. Obeng; Marks, G.B.; Long, R.; Elwood, K.; Zielinski, D.; Gninafon, M.; Wulandari, D.A.; Apriani, L.; Valiquette, C.; Fregonese, F.; Hornby, K.; Li, P.-Z.; Hill, P.C.; Schwartzman, K.; Benedetti, A.; Menzies, D.
    BACKGROUND The treatment of latent infection with Mycobacterium tuberculosis is important in children because of their vulnerability to life-threatening forms of tuberculosis disease. The current standard treatment — 9 months of isoniazid — has been associated with poor adherence and toxic effects, which have hampered the ef- fectiveness of the drug. In adults, treatment with 4 months of rifampin has been shown to be safer and to have higher completion rates than 9 months of isoniazid. METHODS In this multicenter, open-label trial, we randomly assigned 844 children (<18 years of age) with latent M. tuberculosis infection to receive either 4 months of rifampin or 9 months of isoniazid. The primary outcome was adverse events of grade 1 to 5 that resulted in the permanent discontinuation of a trial drug. Secondary outcomes were treatment adherence, side-effect profile, and efficacy. Independent review panels whose members were unaware of trial-group assignments adjudicated all adverse events and progression to active tuberculosis. RESULTS Of the children who underwent randomization, 829 were eligible for inclusion in the modified intention-to-treat analysis. A total of 360 of 422 children (85.3%) in the rifampin group completed per-protocol therapy, as compared with 311 of 407 (76.4%) in the isoniazid group (adjusted difference in the rates of treatment completion, 13.4 percentage points; 95% confidence interval [CI], 7.5 to 19.3). There were no significant between-group differences in the rates of adverse events, with fewer than 5% of the children in the combined groups with grade 1 or 2 ad- verse events that were deemed to be possibly related to a trial drug. Active tuber- culosis, including 1 case with resistance to isoniazid, was diagnosed in 2 children in the isoniazid group during 542 person-years of follow-up, as compared with no cases in the rifampin group during 562 person-years (rate difference, −0.37 cases per 100 person-years; 95% CI, −0.88 to 0.14). CONCLUSIONS Among children under the age of 18 years, treatment with 4 months of rifampin had similar rates of safety and efficacy but a better rate of adherence than 9 months of treatment with isoniazid. (Funded by the Canadian Institutes of Health Research and Conselho Nacional de Pesquisa; ClinicalTrials.gov number, NCT00170209.).