Treatment for preventing tuberculosis in children and adolescents: A randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and Isoniazid

JAMA Pediatrics

Volumn 169, Issue 3, 2015, Pages 247-255

  Villarino, M Elsa ^a   Scott, Nigel A ^a,b   Weis, Stephen E ^c   Weiner, Marc ^d   Conde, Marcus B ^e   Jones, Brenda ^f   Nachman, Sharon ^g   Oliveira, Ricardo ^e   Moro, Ruth N ^a,b   Shang, Nong ^a   Goldberg, Stefan V ^a   Sterling, Timothy R ^h  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b CDC FOUNDATION   (United States)

^c UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER   (United States)

^d VETERANS AFFAIRS MEDICAL CENTER   (United States)

^e FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

^f UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^g STONY BROOK UNIVERSITY   (United States)

^h VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ISONIAZID; RIFAPENTINE; RIFAMPICIN; TUBERCULOSTATIC AGENT;

ADOLESCENT; ARTICLE; BRAZIL; CANADA; CHILD; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; FLU LIKE SYNDROME; GASTROINTESTINAL SYMPTOM; HONG KONG; HUMAN; INFECTION PREVENTION; LATENT TUBERCULOSIS; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; ORAL BLISTER; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SPAIN; TREATMENT OUTCOME; UNITED STATES; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DRUG COMBINATION; PRESCHOOL CHILD;

ADOLESCENT; ANTITUBERCULAR AGENTS; CHILD; CHILD, PRESCHOOL; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; ISONIAZID; LATENT TUBERCULOSIS; MALE; RIFAMPIN; TREATMENT OUTCOME;

EID: 84924273796     PISSN: 21686203     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamapediatrics.2014.3158     Document Type: Article

References (34)

1. Swaminathan S, Rekha B. Pediatric tuberculosis: Global overview and challenges. Clin Infect Dis. 2010;50(suppl 3):S184-S194
2. World Health Organization. Global Tuberculosis Report 2012. Geneva, Switzerland: World Health Organization; 2012.
3. Perez-Velez CM, Marais BJ. Tuberculosis in children. N Engl J Med. 2012;367(4):348-361
4. Ferebee SH. An epidemiological model of tuberculosis in the United States. Bull Nat Tubercu Assoc. 1967;53:4-7
5. Heymann SJ, Brewer TF, Wilson ME, Colditz GA, Fineberg HV. Pediatric tuberculosis: what needs to be done to decrease morbidity and mortality. Pediatrics. 2000;106(1):1
6. Morrison J, PaiM, Hopewell PC. Tuberculosis and latent tuberculosis infection in close contacts of people with pulmonary tuberculosis in low-income and middle-income countries: A systematic review and meta-analysis. Lancet Infect Dis. 2008;8(6):359-368
7. Rutherford ME, Hill PC, Triasih R, Sinfield R, van Crevel R, Graham SM. Preventive therapy in children exposed to Mycobacterium tuberculosis: Problems and solutions. Trop Med Int Health. 2012; 17(10):1264-1273
8. Lincoln EM. The effect of antimicrobial therapy on the prognosis of primary tuberculosis in children. Am Rev Tuberc. 1954;69(5):682-689
9. Lincoln EM, Vera Cruz PG. Progress in treatment of tuberculosis: Results of antimicrobial therapy in a group of 420 children with tuberculosis. Pediatrics. 1960;25(6):1035-1042
10. Ferebee S, Mount FW, Anastasiades A. Prophylactic effects of isoniazid on primary tuberculosis in children: A preliminary report. Am Rev Tuberc. 1957;76(6):942-963
11. Ferebee SH. Controlled chemoprophylaxis trials in tuberculosis: A general review. Bibl Tuberc. 1970; 26:28-106
12. International Union Against Tuberculosis Committee on Prophylaxis. Efficacy of various durations of isoniazid preventive therapy for tuberculosis: Five years of follow-up in the IUAT trial. BullWorld Health Organ. 1982;60(4):555-564
13. Horsburgh CR Jr, Goldberg S, Bethel J, et al; Tuberculosis Epidemiologic Studies Consortium. Latent TB infection treatment acceptance and completion in the United States and Canada. Chest. 2010;137(2):401-409
14. Spyridis NP, Spyridis PG, Gelesme A, et al. The effectiveness of a 9-month regimen of isoniazid alone versus 3- and 4-month regimens of isoniazid plus rifampin for treatment of latent tuberculosis infection in children: Results of an 11-year randomized study. Clin Infect Dis. 2007;45(6):715-722
15. van Zyl S, Marais BJ, Hesseling AC, Gie RP, Beyers N, Schaaf HS. Adherence to anti-tuberculosis chemoprophylaxis and treatment in children. Int J Tuberc Lung Dis. 2006;10(1):13-18
16. Pediatric Tuberculosis Collaborative Group. Targeted tuberculin skin testing and treatment of latent tuberculosis infection in children and adolescents. Pediatrics. 2004;114(4):1175-1201. doi: 10.1542/peds.2004-0809
17. Centers for Disease Control and Prevention. Latent tuberculosis infection: A guide for primary health care providers. Bethesda, MD: US Dept of Health and Human Services, Centers for Disease Control and Prevention; 2013. http://www.cdc.gov /tb/publications/LTBI/default.htm. Accessed November 22, 2014
18. Sterling TR, VillarinoME, Borisov AS, et al; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011;365(23): 2155-2166
19. Schechter M, Zajdenverg R, Falco G, et al. Weekly rifapentine/isoniazid or daily rifampin/pyrazinamide for latent tuberculosis in household contacts. Am J Respir Crit Care Med. 2006;173(8):922-926
20. Martinson NA, Barnes GL, Moulton LH, et al. New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med. 2011;365(1):11-20
21. Centers for Disease Control and Prevention. Recommendations for use of an isoniazid-rifapentine regimen with direct observation to treat latent Mycobacterium tuberculosis infection.MMWRMorb Mortal Wkly Rep. 2011;60(48):1650-1653
22. Blake MJ, Abdel-Rahman SM, Jacobs RF, Lowery NK, Sterling TR, Kearns GL. Pharmacokinetics of rifapentine in children. Pediatr Infect Dis J. 2006;25(5):405-409
23. Peloquin CA, Durbin D, Childs J, Sterling TR, Weiner M. Stability of antituberculosis drugs mixed in food. Clin Infect Dis. 2007;45(4):521
24. Food and Drug Administration. Guidance for industry and investigators on safety reporting requirements for investigational new drug applications and BA/BE studies.Washington, DC: US Dept of Health and Human Services, Food and Drug Administration; 2012. http://www.fda.gov /downloads/drugs /guidancecomplianceregulatoryinformation /guidances/ucm227351.pdf. Accessed November 22, 2014
25. Cancer Therapy Evaluation Program. Common terminology criteria for adverse events. Bethesda, MD: National Cancer Institute, US National Institutes of Health; 1999 http://ctep.cancer.gov /protocoldevelopment/electronic-applications /docs/ctcv20-4-30-992.pdf. Accessed November 22, 2014
26. American Thoracic Society; US Department of Health and Human Services; US Public Health Service; Centers for Disease Control and Prevention. Diagnostic standards and classification of tuberculosis in adults and children.Washington, DC: US Dept of Health and Human Services, Public Health Service; 2000
27. Pickering LK, Baker CJ, Kimberlin DW, Long SS. Red Book: 2012 Report of the Committee on Infectious Diseases. Elk Grove Village, IL: American Academy of Pediatrics; 2012
28. Agresti AC, Brent A. Approximate is better than "exact" for interval estimation ofs binomial proportions. Am Stat. 1998;52(2):119-126. doi: 10.2307/2685469
29. Newcombe RG. Interval estimation for the difference between independent proportions: Comparison of elevenmethods. Stat Med. 1998;17 (8):873-890
30. Brent AJ, Anderson ST, Kampmann B. Childhood tuberculosis: out of sight, out of mind? Trans R Soc Trop Med Hyg. 2008;102(3):217-218
31. BurmanWJ, CottonMF, Gibb DM,Walker AS, Vernon AA, Donald PR. Ensuring the involvement of children in the evaluation of new tuberculosis treatment regimens. PLoS Med. 2008;5(8):e176
32. Starke JR. Childhood tuberculosis: Treatment strategies and recent advances. Paediatr Respir Rev. 2001;2(2):103-112
33. Weiner MS, Mac KenzieWR, Wing D, et al. Rifapentine pharmacokinetics and tolerability in children and adults treated once weekly with rifapentine and isoniazid for latent tuberculosis infection [published online January 16, 2014]. J Ped Infect Dis Soc. doi:10.1093/jpids/pit077
34. World Health Organization. Guidelines on the management of latent tuberculosis infection. Geneva, Switzerland:World Health Organization; 2015. http: //www.who.int/tb/publications/ltbi-document-page/en/. Accessed November 22, 2014.