The hollow fiber system model of tuberculosis (HFS-TB) is designed to perform pharmacokinetics/pharmacodynamics (PK/PD) experiments, and hence the design of optimal doses and dose schedules for the treatment of tuberculosis. To determine if this model is useful for deriving PK/PD data relevant to clinical outcomes, we compared its quantitative output to that from clinical trials.
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The data were collected by searching records of tuberculosis (TB) division of microbiology laboratory in 1999 and 2001, retrospectively.
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Tuberculosis (TB) is the leading infectious cause of death today and 3.81 million cases occurred in 1997 and 1998. Even today in spite of having four drugs like isoniazid, rifampicin, streptomycin/pyrazinamide and ethambutol for the intensive phase, the total duration of treatment remains six months. Because of the global health problems of TB, the increasing rate of multidrug resistant TB (MDR-TB) and the high rate of co-infection with HIV, the need for effective non-toxic antituberculous agents is essential. Fluoroquinolones have been classified as drugs having low bactericidal activity by the WHO. To date, they have been used for preventive therapy, empirical treatment of patients with TB and retreatment of patients with relapsing TB. In-vitro and in-vivo clinical studies have identified ofloxacin as a promising new agent in the treatment of MDR-TB. Ofloxacin has been advocated by the WHO in case of MDR-TB, when susceptibility to test results are not available before starting the new treatment, in the continuation period (18 months) and if resistance is proven to at least isoniazid and rifampicin.
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This study provides with a first insight on Mycobacterium tuberculosis complex epidemiology and genetic diversity in the Cross River State, Nigeria. Starting with 137 smear positive patients recruited over a period of 12months (June 2008 to May 2009), we obtained 97 pure mycobacterial isolates out of which 81 (83.5%) were identified as M. tuberculosis complex. Genotyping revealed a total of 27 spoligotypes patterns with 10 clusters (n=64% or 79% of clustered isolates, 2-32 isolates/cluster), with patients in the age group range 25-34 years being significantly associated with shared-type pattern SIT61 (p=0.019). Comparison with SITVIT2 database showed that with the exception of a single cluster (SIT727/H1), all other clusters observed were representative of West Africa; the two main lineages involved were LAM10-CAM (n=42/81% or 51.8%) of M. tuberculosis and AFRI_2 sublineage of Mycobacterium africanum (n=27/81% or 33.3%). Subsequent 12-loci MIRU typing resulted in a total of 13 SIT/MIT clusters (n=52 isolates, 2-9 isolates per cluster), with a resulting recent n-1 transmission rate of 48.1%. Available drug-susceptibility testing (DST) results for 58/81 clinical isolates revealed 6/58% or 10.4% cases of multiple drug-resistance (MDR); 5/6 MDR cases were caused by strains belonging to LAM10-CAM lineage (a specific cluster SIT61/MIT266 in 4/6 cases, and an orphan spoligotype pattern in 1/6 case). Additionally, MIT266 was associated with streptomycin resistance (p=0.016). All the six MDRTB isolates were concomitantly resistance to streptomycin and ethambutol; however, 4/6 MDR strains with identical MIRU patterns were characterized by consecutive strain numbers hence the possibility of laboratory cross contamination could not be excluded in 3/4 serial cases. The present preliminary study underlines the usefulness of spoligotyping and 12-loci MIRU-VNTRs to establish a baseline of circulating genotypic lineages of M. tuberculosis complex in Nigeria.
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We identified five RCTs (1330 participants) that met the inclusion criteria. None of the included trials examined regimens of less than six months duration. Fluoroquinolones added to standard regimensA single trial (174 participants) added levofloxacin to the standard first-line regimen. Relapse and treatment failure were not reported. For death, sputum conversion, and adverse events we are uncertain if there is an effect (one trial, 174 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for ethambutol in standard regimens Three trials (723 participants) substituted ethambutol with moxifloxacin, gatifloxacin, and ofloxacin into the standard first-line regimen. For relapse, we are uncertain if there is an effect (one trial, 170 participants, very low quality evidence). No trials reported on treatment failure. For death, sputum culture conversion at eight weeks, or serious adverse events we do not know if there was an effect (three trials, 723 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for isoniazid in standard regimens A single trial (433 participants) substituted moxifloxacin for isoniazid. Treatment failure and relapse were not reported. For death, sputum culture conversion, or serious adverse events the substitution may have little or no difference (one trial, 433 participants, low quality evidence for all three outcomes). Fluoroquinolines in four month regimensSix trials are currently in progress testing shorter regimens with fluoroquinolones.
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Enlargement of lymph nodes during treatment of Tuberculous lymphadenitis is well recognized phenomenon in HIV infected patient with ample literature to help guide management. On the contrary, it poses a clinical challenge to distinguish between paradoxical reaction and treatment failure in HIV-seronegative patients and require high index of suspicion.
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Although osteoarticular side effects of the Bacillus Calmette-Guérin (BCG) are rare compared to the number of administrations, BCG vaccination and cancer therapy are so widely used that the absolute number of cases is not negligible. Osteoarticular infection is an exceedingly rare complication of vaccination with the BCG. Intravesical BCG instillations used to treat superficial bladder cancer may cause arthralgia, reactive arthritis or osteoarticular infections. Intradermal BCG therapy used to treat a number of malignancies can cause osteoarticular infections or bilateral symmetric polyarthritis predominating in the wrists and fingers. In practice, when intravesical BCG instillation is followed by arthritis, hyperthermia is unhelpful for distinguishing septic arthritis from reactive arthritis. Arguments pointing to reactive arthritis include oligo- or polyarticular involvement and onset a few weeks (as opposed to a few months) after the last instillation. Nevertheless, joint fluid examination is in order to rule out septic arthritis. BCG-induced reactive arthritis usually responds well to nonsteroidal anti-inflammatory drugs. Osteoarticular infections related to BCG therapy should be treated by rifampin, isoniazid and ethambutol for 2 months, followed by rifampin and isoniazid for 10 months.