Dosing regimens of oral ciprofloxacin for children with severe malnutrition: A population pharmacokinetic study with Monte Carlo simulation

Journal of Antimicrobial Chemotherapy

Volumn 66, Issue 10, 2011, Pages 2336-2345

  Thuo, Nahashon ^a   Ungphakorn, Wanchana ^b   Karisa, Japhet ^a   Muchohi, Simon ^a   Muturi, Alex ^a   Kokwaro, Gilbert ^c,d   Thomson, Alison H ^b,e   Maitland, Kathryn ^a,f  

^a KEMRI WELLCOME TRUST RESEARCH PROGRAMME   (Kenya)

^b UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^c UNIVERSITY OF NAIROBI   (Kenya)

^d The Consortium for National Health Research (CNHR)   (Kenya)

^e NHS GREATER GLASGOW AND CLYDE   (United Kingdom)

^f WELLCOME TRUST SANGER INSTITUTE   (United Kingdom)

Author keywords

Drug absorption; Gram negative; Kwashiorkor; Marasmus; Quinolone

Indexed keywords

AMPICILLIN; CIPROFLOXACIN; GENTAMICIN; SODIUM ION;

ANTIMICROBIAL THERAPY; AREA UNDER THE CURVE; ARTICLE; CHILD; DISEASE SEVERITY; DRUG ABSORPTION; DRUG CLEARANCE; DRUG TOLERABILITY; ESCHERICHIA COLI; FEMALE; FOOD INTAKE; GRAM NEGATIVE BACTERIUM; HUMAN; INFANT; KLEBSIELLA PNEUMONIAE; MAJOR CLINICAL STUDY; MALE; MALNUTRITION; MONTE CARLO METHOD; PHARMACODYNAMICS; PHARMACOKINETICS; PRESCHOOL CHILD; PSEUDOMONAS AERUGINOSA; SCHOOL CHILD; SEPSIS; SODIUM BLOOD LEVEL; TREATMENT DURATION; TREATMENT RESPONSE;

ADMINISTRATION, ORAL; ANTI-BACTERIAL AGENTS; BACTEREMIA; CHILD; CHILD, PRESCHOOL; CIPROFLOXACIN; DEHYDRATION; DRUG RESISTANCE, MULTIPLE, BACTERIAL; ESCHERICHIA COLI; FEMALE; HUMANS; INFANT; KLEBSIELLA PNEUMONIAE; MALE; MALNUTRITION; MICROBIAL SENSITIVITY TESTS; MONTE CARLO METHOD; PSEUDOMONAS AERUGINOSA; SALMONELLA;

EID: 80052880107     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dkr314     Document Type: Article

References (48)

1. Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull WHO 1996; 74: 223-9.
2. Ashworth A, Chopra M, McCoy D et al. WHO guidelines for management of severe malnutrition in rural South African hospitals: effect on case fatality and the influence of operational factors. Lancet 2004; 363: 1110-5.
3. Deen JL, Funk M, Guevara VC et al. Implementation of WHO guidelines on management of severe malnutrition in hospitals in Africa. Bull WHO 2003; 81: 237-43.
4. Maitland K, Berkley JA, Shebbe M et al. Children with severe malnutrition: can those at highest risk of death be identified with the WHO protocol? PLoS Medicine 2006; 3: e500.
5. Bachou H, Tylleskär T, Kaddu-Mulindwa DH et al. Bacteraemia among severely malnourished children infected and uninfected with the human immunodeficiency virus-1 in Kampala, Uganda. BMC Infect Dis 2006; 6: 160.
6. Babirekere-Iriso E, Musoke P, Kekitiinwa A. Bacteraemia in severely malnourished children in an HIV-endemic setting. Ann Trop Paediatrics 2006; 26: 319-28.
7. Welsh FK, Farmery SM, MacLennan K et al. Gut barrier function in malnourished patients. Gut 1998; 42: 396-401.
8. Brewster DR, Manary MJ, Menzies IS et al. Intestinal permeability in kwashiorkor. Arch Dis Childhood 1997; 76: 236-41.
9. World Health Organization. Management of Severe Malnutrition: A Manual for Physicians and Other Senior Health Workers. Geneva: WHO, 1999.
10. Seaton C, Ignas J, Muchohi S et al. Population pharmacokinetics of a single daily intramuscular dose of gentamicin in children with severe malnutrition. J Antimicrob Chemother 2007; 59: 681-9.
11. Cruciani M, Bassetti D. The fluoroquinolones as treatment for infections caused by Gram-positive bacteria. J Antimicrob Chemother 1994; 33: 403-17.
12. Burkhardt JE, Hill MA, Carlton WW et al. Histologic and histochemical changes in articular cartilages of immature beagle dogs dosed with difloxacin, a fluoroquinolone. Vet Pathol 1990; 27: 162-70.
13. Committee on Infectious Diseases. The use of systemic fluoroquinolones. Pediatrics 2006; 118: 1287-92.
14. Paediatric Formulary Committee. British National Formulary for Children, 2009 edn. London: British Medical Association, the Royal Pharmaceutical Society of Great Britain, the Royal College of Paediatrics and Child Health, and the Neonatal and Paediatric Pharmacists Group, 2009.
15. Drusano GL, Standiford HC, Plaisance K et al. Absolute oral bioavailability of ciprofloxacin. Antimicrob Agents Chemother 1986; 30: 444-6.
16. Payen S, Serreau R, Munck A et al. Population pharmacokinetics of ciprofloxacin in pediatric and adolescent patients with acute infections. Antimicrob Agents Chemother 2003; 47: 3170-8.
17. Rajagopalan P, Gastonguay MR. Population pharmacokinetics of ciprofloxacin in pediatric patients. J Clin Pharmacol 2003; 43: 698-710.
18. Schaefer H, Stass H, Wedgwood J et al. Pharmacokinetics of ciprofloxacin in pediatric cystic fibrosis patients. Antimicrob Agents Chemother 1996; 40: 29-34.
19. Peltola H, Väärälä M, Renkonen OV et al. Pharmacokinetics of single-dose oral ciprofloxacin in infants and small children. Antimicrob Agents Chemother 1992; 36: 1086-90.
20. Muchohi SN, Thuo N, Karisa J et al. Determination of ciprofloxacin in human plasma using high-performance liquid chromatography coupled with fluorescence detection: application to a population pharmacokinetics study in children with severe malnutrition. J Chromatog B, Analyt Technol Biomed Life Sci 2011; 879: 146-52.
21. Beal SL, Sheiner LB, Boeckmann AJ, eds. NONMEM Users Guides (1989-2006). Ellicott City: Icon Development Solutions.
22. Jonsson EN, Karlsson MO. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comp Method Prog Biomed 1999; 58: 51-64.
23. Venables WN, Smith DM, R Development Core Team. R version 2.9.2. The R Foundation for Statistical Computing, 2009. http://cran. r-project.org (7 July 2010, date last accessed).
24. Savic RM, Jonker DM, Kerbusch T et al. Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodynam 2007; 34: 711-26.
25. Holford NH. A size standard for pharmacokinetics. Clin Pharmacokinet 1996; 30: 329-32.
26. Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984; 104: 849-54.
27. Schwartz GJ, Gauthier B. A simple estimate of glomerular filtration rate in adolescent boys. J Pediatrics 1985; 106: 522-6.
28. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comp Method Prog Biomed 2004; 75: 85-94.
29. Wallin JR, Bergstrand M, Karlsson MO et al. Internal and external validation with sparse, adaptive-design data for evaluating the predictive performance of tacrolimus. In: Abstracts of the Annual Meeting of the Population Approach Group in Europe, Berlin, 2010. PAGE 19 (2010) Abstr 1851. www.page-meeting.org/?abstract=1851 (10 January 2011, date last accessed).
30. Brendel K, Comets E, Laffont C et al. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 2006; 23: 2036-49.
31. Forrest A, Nix DE, Ballow CH et al. Pharmacodynamics of intravenous ciprofloxacin in seriously ill patients. Antimicrob Agents Chemother 1993; 37: 1073-81.
32. European Committee on Antimicrobial Susceptibility Testing. EUCAST MIC- and Zone Diameter Breakpoint Tables, 2011. http://www.eucast. org/eucast_disk_diffusion_test/breakpoints/ (10 January 2011, date last accessed).
33. Peltola H, Ukkonen P, Saxén H et al. Single-dose and steady-state pharmacokinetics of a new oral suspension of ciprofloxacin in children. Pediatrics 1998; 101: 658-62.
34. MacGowan A, Rogers C, Bowker K. The use of in vitro pharmacodynamic models of infection to optimize fluoroquinolone dosing regimens. J Antimicrob Chemother 2000; 46: 163-70.
35. Montgomery MJ, Beringer PM, Aminimanizani A et al. Population pharmacokinetics and use of Monte Carlo simulation to evaluate currently recommended dosing regimens of ciprofloxacin in adult patients with cystic fibrosis. Antimicrob Agents Chemother 2001; 45: 3468-73.
36. van Zanten ARH, Polderman KH, van Geijlswijk IM et al. Ciprofloxacin pharmacokinetics in critically ill patients: a prospective cohort study. J Crit Care 2008; 23: 422-30.
37. Forrest A, Weir M, Plaisance KI et al. Relationships between renal function and disposition of oral ciprofloxacin. Antimicrob Agents Chemother 1988; 32: 1537-40.
38. Gasser TC, Ebert SC, Graversen PH et al. Ciprofloxacin pharmacokinetics in patients with normal and impaired renal function. Antimicrob Agents Chemother 1987; 31: 709-12.
39. Plaisance KI, Drusano GL, Forrest A et al. Effect of renal function on the bioavailability of ciprofloxacin. Antimicrob Agents Chemother 1990; 34: 1031-4.
40. Rubio TT, Miles MV, Lettieri JT et al. Pharmacokinetic disposition of sequential intravenous/oral ciprofloxacin in pediatric cystic fibrosis patients with acute pulmonary exacerbation. Pediatr Infect Dis J 1997; 16: 112-7; discussion 123-6.
41. Frost RW, Lasseter KC, Noe AJ et al. Effects of aluminum hydroxide and calcium carbonate antacids on the bioavailability of ciprofloxacin. Antimicrob Agents Chemother 1992; 36: 830-2.
42. Neuvonen PJ, Kivistö KT, Lehto P. Interference of dairy products with the absorption of ciprofloxacin. Clin Pharmacol Ther 1991; 50: 498-502.
43. Nix DE, Watson WA, Lener ME et al. Effects of aluminum and magnesium antacids and ranitidine on the absorption of ciprofloxacin. Clin Pharmacol Ther 1989; 46: 700-5.
44. Drusano GL, Weir M, Forrest A et al. Pharmacokinetics of intravenously administered ciprofloxacin in patients with various degrees of renal function. Antimicrob Agents Chemother 1987; 31: 860-4.
45. Lipman J, Gous AGS, Mathivha LR et al. Ciprofloxacin pharmacokinetic profiles in paediatric sepsis: how much ciprofloxacin is enough? Intens Care Med 2002; 28: 493-500.
46. Alleyne GA. The effect of severe protein calorie malnutrition on the renal function of Jamaican children. Pediatrics 1967; 39: 400-11.
47. Klahr S, Alleyne GA. Effects of chronic protein-calorie malnutrition on the kidney. Kidney Int 1973; 3: 129-41.
48. Lipman J, Scribante J, Gous AG et al. Pharmacokinetic profiles of high-dose intravenous ciprofloxacin in severe sepsis. The Baragwanath Ciprofloxacin Study Group. Antimicrob Agents Chemother 1998; 42: 2235-9.