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Two randomized controlled trials of ceftazidime alone versus ceftazidime in combination with trimethoprim-sulfamethoxazole for the treatment of severe melioidosis.
Clin Infect Dis. 2005 Oct 15; 41(8):1105-13.CI

Abstract

BACKGROUND

Two antibiotic regimens are used commonly in Thailand for the initial treatment of severe melioidosis: ceftazidime in combination with trimethoprim-sulfamethoxazole (TMP-SMX) and ceftazidime monotherapy. It is not known whether TMP-SMX provides an additional benefit.

METHODS

Two prospective, randomized trials that compared these regimens for patients presenting with acute severe melioidosis were started independently at tertiary care hospitals in Ubon Ratchathani and Khon Kaen (in northeastern Thailand), and the results were analyzed together as a prospective, individual-patient data meta-analysis. The primary end point was in-hospital mortality rate.

RESULTS

The in-hospital mortality rate among all enrolled patients (n=449) was not significantly different between those randomized to ceftazidime alone (25.1%; 56 of 223 subjects) and those randomized to ceftazidime with TMP-SMX (26.6%; 60 of 226 subjects; odds ratio [OR], 1.08; 95% confidence interval [CI], 0.7-1.7; stratified P=.73). Of the 241 patients with culture-confirmed melioidosis, 51 (21.2%) died. Of these 241 patients, 31 (12.9%) died > or =48 h after the time of study entry. Among patients with melioidosis, there was no difference in death rate between the 2 treatment groups for either all deaths (OR, 0.88; 95% CI, 0.48-1.6; stratified P=.70) or for deaths that occurred > or =48 h after hospital admission (OR, 0.88; 95% CI, 0.41-1.9; stratified P=.73). Conditional logistic regression analysis revealed that bacteremia, respiratory failure, and renal failure were independently associated with death and treatment failure. Drug regimens were not associated with death or treatment failure in this model.

CONCLUSION

We conclude that the addition of TMP-SMX to ceftazidime therapy during initial treatment of severe melioidosis does not reduce the acute mortality rate.

Authors+Show Affiliations

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16163628

Citation

Chierakul, Wirongrong, et al. "Two Randomized Controlled Trials of Ceftazidime Alone Versus Ceftazidime in Combination With Trimethoprim-sulfamethoxazole for the Treatment of Severe Melioidosis." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 41, no. 8, 2005, pp. 1105-13.
Chierakul W, Anunnatsiri S, Short JM, et al. Two randomized controlled trials of ceftazidime alone versus ceftazidime in combination with trimethoprim-sulfamethoxazole for the treatment of severe melioidosis. Clin Infect Dis. 2005;41(8):1105-13.
Chierakul, W., Anunnatsiri, S., Short, J. M., Maharjan, B., Mootsikapun, P., Simpson, A. J., Limmathurotsakul, D., Cheng, A. C., Stepniewska, K., Newton, P. N., Chaowagul, W., White, N. J., Peacock, S. J., Day, N. P., & Chetchotisakd, P. (2005). Two randomized controlled trials of ceftazidime alone versus ceftazidime in combination with trimethoprim-sulfamethoxazole for the treatment of severe melioidosis. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 41(8), 1105-13.
Chierakul W, et al. Two Randomized Controlled Trials of Ceftazidime Alone Versus Ceftazidime in Combination With Trimethoprim-sulfamethoxazole for the Treatment of Severe Melioidosis. Clin Infect Dis. 2005 Oct 15;41(8):1105-13. PubMed PMID: 16163628.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Two randomized controlled trials of ceftazidime alone versus ceftazidime in combination with trimethoprim-sulfamethoxazole for the treatment of severe melioidosis. AU - Chierakul,Wirongrong, AU - Anunnatsiri,Siriluck, AU - Short,Jennifer M, AU - Maharjan,Bina, AU - Mootsikapun,Piroon, AU - Simpson,Andrew J H, AU - Limmathurotsakul,Direk, AU - Cheng,Allen C, AU - Stepniewska,Kasia, AU - Newton,Paul N, AU - Chaowagul,Wipada, AU - White,Nicholas J, AU - Peacock,Sharon J, AU - Day,Nicholas P, AU - Chetchotisakd,Ploenchan, Y1 - 2005/09/02/ PY - 2005/01/13/received PY - 2005/06/13/accepted PY - 2005/9/16/pubmed PY - 2006/9/6/medline PY - 2005/9/16/entrez SP - 1105 EP - 13 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 41 IS - 8 N2 - BACKGROUND: Two antibiotic regimens are used commonly in Thailand for the initial treatment of severe melioidosis: ceftazidime in combination with trimethoprim-sulfamethoxazole (TMP-SMX) and ceftazidime monotherapy. It is not known whether TMP-SMX provides an additional benefit. METHODS: Two prospective, randomized trials that compared these regimens for patients presenting with acute severe melioidosis were started independently at tertiary care hospitals in Ubon Ratchathani and Khon Kaen (in northeastern Thailand), and the results were analyzed together as a prospective, individual-patient data meta-analysis. The primary end point was in-hospital mortality rate. RESULTS: The in-hospital mortality rate among all enrolled patients (n=449) was not significantly different between those randomized to ceftazidime alone (25.1%; 56 of 223 subjects) and those randomized to ceftazidime with TMP-SMX (26.6%; 60 of 226 subjects; odds ratio [OR], 1.08; 95% confidence interval [CI], 0.7-1.7; stratified P=.73). Of the 241 patients with culture-confirmed melioidosis, 51 (21.2%) died. Of these 241 patients, 31 (12.9%) died > or =48 h after the time of study entry. Among patients with melioidosis, there was no difference in death rate between the 2 treatment groups for either all deaths (OR, 0.88; 95% CI, 0.48-1.6; stratified P=.70) or for deaths that occurred > or =48 h after hospital admission (OR, 0.88; 95% CI, 0.41-1.9; stratified P=.73). Conditional logistic regression analysis revealed that bacteremia, respiratory failure, and renal failure were independently associated with death and treatment failure. Drug regimens were not associated with death or treatment failure in this model. CONCLUSION: We conclude that the addition of TMP-SMX to ceftazidime therapy during initial treatment of severe melioidosis does not reduce the acute mortality rate. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/16163628/Two_randomized_controlled_trials_of_ceftazidime_alone_versus_ceftazidime_in_combination_with_trimethoprim_sulfamethoxazole_for_the_treatment_of_severe_melioidosis_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/444456 DB - PRIME DP - Unbound Medicine ER -