Sputum Culture Conversion With Moxifloxacin-Containing Regimens in the Treatment of Patients With Newly Diagnosed Sputum-Positive Pulmonary Tuberculosis in South India

Velayutham, Banurekha; Allaudeen, Iliayas S.; Sivaramakrishnan, Gomathi; Venkatesan, P; Nair, Dina; C, George Priya Doss; Paramasivam, Paul K.; Baskaran, Dhanaraj; Santhanakrishnan, Ramesh; Navaneethapandian, Gangadevi P.; Marimuthu, Makesh K.; Kumar, Vanaja; Chandrasekaran, K.; Dharuman, Kalaiselvi; Elangovan, Thiruvalluvan; Meenakshi, N.; Ramaswamy, Sridhar; Vadivelu, Gangadharan; Rathinam, Prabhakaran; Chandrasekar, C; Jayabal, Lavanya; Swaminathan, Soumya; Shaheed, Jawahar M.

doi:10.1093/cid/ciu550

Cited by 21 publications

(28 citation statements)

References 15 publications

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“…A drug safety review of clinical data comparing safety and risk of adverse events in patients on moxifloxacin with similar comparator drugs found no significantly increased risk of adverse events with moxifloxacin . Phase 2 or 3 studies conducted in patients with tuberculosis (Table ) did not report any significant difference in the incidence of grade 3 or 4 adverse events between moxifloxacin‐containing arms of the study and standard treatment regimens . In keeping with other non‐TB studies, moxifloxacin significantly increased rates of nausea and GI upset and arthralgia compared to standard TB therapy .…”

Section: Resultsmentioning

confidence: 51%

“…In studies in which moxifloxacin replaced ethambutol or isoniazid in the standard drug regimen, no statistically significant difference was found in sputum culture conversion at 8 weeks of treatment except in 2 studies conducted in Brazil and India, which reported favorable activity for the moxifloxacin‐containing regimens . However, moxifloxacin‐containing regimens resulted in significantly higher proportions of sputum culture conversion at time points earlier than 8 weeks .…”

Section: Resultsmentioning

confidence: 99%

“…Drug regimens used in these studies either replaced ethambutol or isoniazid with moxifloxacin, or added moxifloxacin to, the standard first line drug regimen or tested novel drugs, bedaquiline, or pretomanid with moxifloxacin and pyrazinamide. All studies included patients with sputum smear‐positive TB, mainly HIV uninfected, and most studies reported 60% to 70% or greater cavitation at baseline …”

Section: Resultsmentioning

confidence: 99%

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A Review of Moxifloxacin for the Treatment of Drug‐Susceptible Tuberculosis

Naidoo

McIlleron

et al. 2017

The Journal of Clinical Pharma

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Moxifloxacin, an 8-methoxy quinolone, is an important drug in the treatment of multidrug-resistant tuberculosis (MDR TB) and is being investigated in novel drug regimens with pretomanid, bedaquiline and pyrazinamide, or rifapentine, for the treatment of drug-susceptible tuberculosis. Early results of these studies are promising. Although current evidence does not support the use of moxifloxacin in treatment shortening regimens for drug-susceptible tuberculosis, it may be recommended in patients unable to tolerate standard first-line drug regimens or for isoniazid mono-resistance. Evidence suggests that the standard 400mg dose of moxifloxacin used in the treatment of tuberculosis may be suboptimal in some patients leading to worse tuberculosis treatment outcomes and emergence of drug resistance. Furthermore, a drug interaction with the rifamycins results in up to 31% reduced plasma concentrations of moxifloxacin when combined for treatment of drug-susceptible tuberculosis, although the clinical relevance of this interaction is unclear. Moxifloxacin exhibits extensive inter-individual pharmacokinetic variability. Higher doses of moxifloxacin may be needed to achieve drug exposures required for improved clinical outcomes. Further study is however needed, to determine the safety of proposed higher doses and clinically validated targets for drug exposure to moxifloxacin associated with improved tuberculosis treatment outcomes. We discuss in this review, the evidence for the use of moxifloxacin in drug-susceptible tuberculosis and explore the role of moxifloxacin pharmacokinetics, pharmacodynamics and drug interactions with rifamycins, on tuberculosis treatment outcomes when used in first-line tuberculosis drug regimens.

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Section: Resultsmentioning

confidence: 51%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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A Review of Moxifloxacin for the Treatment of Drug‐Susceptible Tuberculosis

Naidoo

McIlleron

et al. 2017

The Journal of Clinical Pharma

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“…Based on these data one can speculate that sputum smear conversion may actually be giving a false negative signal and one should trust sputum culture conversion to evaluate cure rate since the acid test for clearance of the detectable bacilli would be culture negativity. Support for this also comes from recent studies where sputum culture conversion has been considered as the only widely accepted marker of sterilizing activity and efficacy and used for monitoring therapy in patients with pulmonary TB which is crucial to avoid relapses 12, 33–35 . Time to culture conversion which effectively shows mycobacterial elimination, has been used in several trials to evaluate the efficacies of drugs like moxifloxacin, ciprofloxacin etc.…”

Section: Discussionmentioning

confidence: 99%

“…Time to culture conversion which effectively shows mycobacterial elimination, has been used in several trials to evaluate the efficacies of drugs like moxifloxacin, ciprofloxacin etc. in tuberculosis 35–38 . Perrin et al .…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial

Sharma

Katoch

Sarin

et al. 2017

Sci Rep

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Prolonged treatment of tuberculosis (TB) often leads to poor compliance, default and relapse, converting primary TB patients into category II TB (Cat IITB) cases, many of whom may convert to multi-drug resistant TB (MDR-TB). We have evaluated the immunotherapeutic potential of Mycobacterium indicus pranii (MIP) as an adjunct to Anti-Tubercular Treatment (ATT) in Cat II pulmonary TB (PTB) patients in a prospective, randomized, double blind, placebo controlled, multicentric clinical trial. 890 sputum smear positive Cat II PTB patients were randomized to receive either six intra-dermal injections (2 + 4) of heat-killed MIP at a dose of 5 × 108 bacilli or placebo once in 2 weeks for 2 months. Sputum smear and culture examinations were performed at different time points. MIP was safe with no adverse effects. While sputum smear conversion did not show any statistically significant difference, significantly higher number of patients (67.1%) in the MIP group achieved sputum culture conversion at fourth week compared to the placebo (57%) group (p = 0.0002), suggesting a role of MIP in clearance of the bacilli. Since live bacteria are the major contributors for sustained incidence of TB, the potential of MIP in clearance of the bacilli has far reaching implications in controlling the spread of the disease.

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Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis

Grace

Mittal

Jain

et al. 2019

Cochrane Database of Systematic Reviews

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Sputum Culture Conversion With Moxifloxacin-Containing Regimens in the Treatment of Patients With Newly Diagnosed Sputum-Positive Pulmonary Tuberculosis in South India

Abstract: A 5-drug daily regimen with moxifloxacin results in significantly higher sputum culture conversion in the first 2 months compared with a thrice-weekly, 4-drug regimen in patients with newly diagnosed sputum-positive pulmonary tuberculosis.

Cited by 21 publications

References 15 publications

A Review of Moxifloxacin for the Treatment of Drug‐Susceptible Tuberculosis

A Review of Moxifloxacin for the Treatment of Drug‐Susceptible Tuberculosis

Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial

Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis

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