Addition of Amikacin and Levofloxacin is Associated with Higher Culture Conversion Rate in Pulmonary Tuberculosis

Objective: To study that addition of Amikacin and Levofloxacin to the standard anti-tuberculosis regimen is associated with higher culture conversion rate at 02 months. Study Design: Randomized controlled trial Place and Duration of Study: Department of Medicine CMH Lahore Medical College January 2009 to December 2010. Materials and Methods: Hundred patients with sputum culture positive tuberculosis were selected by non probability convenient sampling. Patients were divided into two groups by randomization. Group1 received HREZ (INH, Rifampicin, and Ethambutol and PZA) and Group2 received two additional drugs i.e. Levofloxacin per oral daily and injection Amikacin IV daily. Sputum culture was repeated at the end of 02 months of treatment and percentage of culture conversion in each group was determined. Data was collected through a carefully designed structured data collection form and analyzed by SPSS version 18. Frequencies and percentages of different variables were calculated. Comparison of means was done by student t test and frequencies and percentages were compared by chi square test and fisher exact test. P value < 0.05 was considered significant. Results: Mean age was 48.46+/-17.76 and 50.82+/-17.59 (P=0.506) in Group1and Group2, respectively. Group1 included 31(62%) male and 19(38%) female while Group2 included 40(80%) male and 10(20%) female (P=0.077). In group 1 (on standard ATT) 42(84%) were culture negative and in group 2(standard ATT plus Levofloxacin and Amikacin) 49(98%) were culture negative at two months (P=0.0309)). Conclusion: Addition of Amikacin and Levofloxacin to standard ATT regimen is associated with higher culture conversion rate at 02 months. The regimen containing Amikacin and Levofloxacin was not associated with any adverse reactions and tolerated well by the patients.