scholarly journals Randomized Dose-Ranging Study of the 14-Day Early Bactericidal Activity of Bedaquiline (TMC207) in Patients with Sputum Microscopy Smear-Positive Pulmonary Tuberculosis

2013 ◽  
Vol 57 (5) ◽  
pp. 2199-2203 ◽  
Author(s):  
Andreas H. Diacon ◽  
Rodney Dawson ◽  
Florian Von Groote-Bidlingmaier ◽  
Gregory Symons ◽  
Amour Venter ◽  
...  
Keyword(s):  
Pulmonary Tuberculosis ◽  
Bactericidal Activity ◽  
Linear Trend ◽  
Sputum Smear ◽  
Sputum Microscopy ◽  
Blinded Study ◽  
Smear Positive Pulmonary Tuberculosis ◽  
Dose Ranging ◽  
Safety Considerations ◽  
Double Blinded

ABSTRACTBedaquiline is a new antituberculosis agent targeting ATP synthase. This randomized, double-blinded study enrolling 68 sputum smear-positive pulmonary tuberculosis patients evaluated the 14-day early bactericidal activity of daily doses of 100 mg, 200 mg, 300 mg, and 400 mg bedaquiline, preceded by loading doses of 200 mg, 400 mg, 500 mg, and 700 mg, respectively, on the first treatment day and 100 mg, 300 mg, 400 mg, and 500 mg on the second treatment day. All groups showed activity with a mean (standard deviation) daily fall in log10CFU over 14 days of 0.040 (0.068), 0.056 (0.051), 0.077 (0.064), and 0.104 (0.077) in the 100-mg, 200-mg, 300-mg, and 400-mg groups, respectively. The linear trend for dose was significant (P= 0.001), and activity in the 400-mg dose group was greater than that in the 100-mg group (P= 0.014). All of the bedaquiline groups showed significant bactericidal activity that was continued to the end of the 14-day evaluation period. The finding of a linear trend for dose suggests that the highest dose compatible with safety considerations should be taken forward to longer-term clinical studies.

Cost-effectiveness of chemotherapy for sputum smear-positive pulmonary tuberculosis in Malawi, Mozambique and Tanzania

1994 ◽  
Vol 9 (2) ◽  
pp. 151-181 ◽  
Author(s):  
Eric De Jonghe ◽  
Christopher J. L. Murray ◽  
H. J. Chum ◽  
D. S. Nyangulu ◽  
A. Salomao ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Pulmonary Tuberculosis ◽  
Sputum Smear ◽  
Smear Positive Pulmonary Tuberculosis

scholarly journals Factors Influencing Sputum Conversion among Smear-Positive Pulmonary Tuberculosis Patients in Morocco

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Khalid Bouti ◽  
Mohammed Aharmim ◽  
Karima Marc ◽  
Mouna Soualhi ◽  
Rachida Zahraoui ◽  
...  
Keyword(s):  
Pulmonary Tuberculosis ◽  
Stepwise Regression ◽  
Control Measures ◽  
Sputum Smear ◽  
Tuberculosis Patients ◽  
Infection Control Measures ◽  
Factors Influencing ◽  
Smear Positive Pulmonary Tuberculosis ◽  
Sputum Conversion ◽  
A Prospective Study

Background. Sputum smear-positive pulmonary tuberculosis patients expel infectious viable bacilli for a period following the commencement of treatment. Objective. To determine the time to sputum smear conversion and study the factors influencing it. Design. A prospective study was undertaken at our hospital in Rabat over a six-month period on a cohort of 119 sputum smear positive patients. Patients were followed up fortnightly. At each followup, specimens were collected and processed for microscopy using standard protocol. Results. 96.6% of our patients completed the study (4 deaths). Sputum conversion rate was 42% after two weeks, 73% after one month, and 95% after two months. Univariate and stepwise regression analysis showed that patients who had high smear grading, miliary, and bilateral radiologic lesions were more likely to undergo delayed sputum conversion (P<0.05). Other factors were thought to influence sputum conversion but were not statistically proven in our study. Conclusion. Since viable bacilli continue to be expelled for up to two months, infection control measures should be maintained for such a time. Patients with high smear grading, miliary, and bilateral radiologic lesions need to be monitored more closely.

scholarly journals Sputum Smear Positive Pulmonary Tuberculosis Diagnostic Dropout Rate in Public Health Facilities, Addis Ababa, Ethiopia

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Daniel Melese Desalegn ◽  
Kumera Terfa Kitila ◽  
Boja Dufera Taddese ◽  
Tinsae Kidanemariam Hailu ◽  
Tariku Takle Dinku ◽  
...  
Keyword(s):  
Public Health ◽  
Pulmonary Tuberculosis ◽  
Addis Ababa ◽  
Dropout Rate ◽  
Sputum Smear ◽  
P Value ◽  
Smear Microscopy ◽  
Sputum Smear Microscopy ◽  
Public Health Facilities ◽  
Smear Positive Pulmonary Tuberculosis

Background. Prolonged laboratory diagnostic process of tuberculosis can lead to failure to complete the diagnosis and increase dropout rate of smear positive pulmonary tuberculosis (PTB) cases. This implies such dropout patients without completing diagnosis are critical as infected individuals remain untreated in the community, providing more opportunities for transmission of the disease and adversely affecting the epidemic. The aim of this research is to determine the level of smear positive PTB diagnosis dropout rate of spot-morning-spot sputum microscopy diagnosis method in public health facilities, in Addis Ababa, Ethiopia. Methods. Retrospective review of patient documents in 13 public health facilities’ TB laboratory in Addis Ababa was conducted from October 2011 to March 2016. Data was computerized using Epi-info software and analysed using SPSS version 20.0 software. Descriptive numerical summaries were used to present the findings. Association between the dropout rate and demographic variables was assessed by Chi-square (X2). Bivariate model using Odds Ratio (OR) with a 95% Confidence Interval (CI) was calculated. P-Value less than 0.05 was taken as statistically significant. Results. Of 41,884 presumptive TB patients registered during the 53 months for laboratory investigation, 5.9% were positive for the first spot sputum smear microscopy. Among these positive cases, 142 (5.8%) and 298 (12.1%) did not come back to the laboratory to submitted early morning and second spot sputum specimens, respectively. The diagnostic dropout for morning sputum specimen in hospitals was 5.6% (58/1039) and in health centres was 5.9% (84/1424). However, higher proportion of dropout for second spot sputum specimen in hospitals was 16.4% (170/1039), compared to the health centres, 8.9% (128/1424). Diagnostic dropout of sputum smear microscopy had no significant association with sociodemographic variable (P value >0.05), while it had significant association with facility type (P value <0.05). Conclusion. In this study smear positive pulmonary tuberculosis diagnostic dropout rate was high compared to WHO reported for the new strategy shift implying the importance of shifting to same-day approach. Hence, shifting from conventional to same day is crucial to minimize the TB diagnostic dropout rate in the study area and other similar settings. Further research is needed/recommended in the local setting to compare the yield and dropout rates between same-day and conventional sputum smear microscopy approach.

scholarly journals Early Bactericidal Activity and Pharmacokinetics of the Diarylquinoline TMC207 in Treatment of Pulmonary Tuberculosis

2008 ◽  
Vol 52 (8) ◽  
pp. 2831-2835 ◽  
Author(s):  
R. Rustomjee ◽  
A. H. Diacon ◽  
J. Allen ◽  
A. Venter ◽  
C. Reddy ◽  
...  
Keyword(s):  
Pulmonary Tuberculosis ◽  
Bactericidal Activity ◽  
Dose Range ◽  
Study Drug ◽  
First Line ◽  
Serious Adverse Events ◽  
Once Daily ◽  
Smear Positive Pulmonary Tuberculosis

ABSTRACT Tibotec Medicinal Compound 207 (TMC207) is a novel diarylquinoline with a unique mode of action that targets mycobacterial ATP synthase. TMC207 exhibits high in vitro activity against mycobacterial strains either susceptible or resistant to all first-line and many second-line drugs, including fluoroquinolones, and has shown exceptional in vivo activity against several mycobacterial species in different animal models. In this early bactericidal activity study, 75 treatment-naïve patients with smear-positive pulmonary tuberculosis were randomized to once-daily oral TMC207 (25 mg, 100 mg, or 400 mg), 600 mg rifampin (RIF), or 300 mg isoniazid (INH) for 7 days. Sixteen-hour overnight sputum collected at baseline and on each treatment day was plated in serial dilutions on selective agar plates. The bactericidal activity was expressed as the log10 decrease in CFU/ml sputum/day. Pharmacokinetic sampling was performed on day 7 of TMC207 administration up to 24 h postdose. The decreases in log10 CFU counts (± standard deviation) from baseline to day 7 were 0.04 ± 0.46 for 25 mg TMC207 (n = 14), 0.26 ± 0.64 for 100 mg TMC207 (n = 14), 0.77 ± 0.58 for 400 mg TMC207 (n = 14), 1.88 ± 0.74 for INH (n = 11), and 1.70 ± 0.71 for RIF (n = 14). Significant bactericidal activity of 400 mg TMC207 was observed from day 4 onward and was similar in magnitude to those of INH and RIF over the same period. The pharmacokinetics of TMC207 were linear across the dose range. In summary, TMC207 demonstrated bactericidal activity with a delayed onset and was well tolerated, and no study drug-related serious adverse events occurred.

scholarly journals A PROSPECTIVE SINGLE-BLINDED STUDY ON THE SAFETY AND EFFICACY OF ZINC SUPPLEMENTATION IN PULMONARY TUBERCULOSIS

2018 ◽  
Vol 11 ◽  
Author(s):  
Yeswanth Prasanna Kumar B ◽  
Praveen D ◽  
Vijey Aanandhi M
Keyword(s):  
Pulmonary Tuberculosis ◽  
Zinc Supplementation ◽  
Serum Zinc ◽  
Sputum Smear ◽  
Safety And Efficacy ◽  
Medication Treatment ◽  
Blinded Study ◽  
Group A ◽  
Group B ◽  
The Given

Aim and Objectives: The aim of the study was to study the serum zinc (Zn) levels, safety, and efficacy of Zn supplementation in pulmonary tuberculosis (PTB) patients.Methods: A randomized single-blinded study of two groups: Group A received conventional TB therapy while Group B received conventional TB therapy along with 15 mg of Zn tablet. 40 patients were assigned in each group by randomized permuted blocks.Results: After 8 weeks of treatment in Group A 27 patients and Group B 36 patients were found to be sputum negative with p=0.0421 and 0.0629. After 24 weeks of treatment in Group A 37 patients and Group B 40 patients were found to be sputum negative with p=0.00976 and 0.00971. By this, the given treatment was effective in the patients with PTB.Conclusion: Zn supplementation improves the effect of TB medication treatment and results in earlier sputum smear conversion.

scholarly journals Early bactericidal activity of a moxifloxacin and isoniazid combination in smear-positive pulmonary tuberculosis

2005 ◽  
Vol 56 (6) ◽  
pp. 1169-1171 ◽  
Author(s):  
Stephen H. Gillespie ◽  
Roly D. Gosling ◽  
Leonard Uiso ◽  
Noel E. Sam ◽  
Esther G. Kanduma ◽  
...  
Keyword(s):  
Pulmonary Tuberculosis ◽  
Bactericidal Activity ◽  
Smear Positive Pulmonary Tuberculosis
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