Multicenter, randomized, double blind clinical trial of short course versus standard course oral ciprofloxacin for Shigella dysenteriae type 1 dysentery in children

Pediatric Infectious Disease Journal

Volumn 21, Issue 12, 2002, Pages 1136-1141

  Bennish, Michael Louis ^d   Khan, Wasif Ali ^d   Kindra, Gurpreet ^a   Mason, Elizabeth Mary ^b   Nathoo, Kusim J ^b   Ries, Allen A ^b   Rollins, Nigel Campbell ^a   Schall, Robert ^c   Sprenger, Ken ^d   Wellington, Maureen ^b   Saha, D ^d   Salam, M A ^d   Karas, J A ^a   Pillay, D G ^a   Sturm, A W ^a   Makombe, R ^b   Mason, P ^b  

^a UNIVERSITY OF KWAZULU NATAL   (South Africa)

^b UNIVERSITY OF ZIMBABWE   (Zimbabwe)

^c IQVIA   (United States)

^d NONE

Author keywords

Bacillary dysentery; Bangladesh; Ciprofloxacin; Efficacy; Safety; Shigella dysenteriae type 1; Shigellosis; South Africa; Zimbabwe

Indexed keywords

CIPROFLOXACIN; PLACEBO;

ANTIBIOTIC RESISTANCE; ARTHRALGIA; ARTICLE; BACTERIAL GROWTH; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSENTERY; FECES CULTURE; FEMALE; HUMAN; JOINT FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SHIGELLA DYSENTERIAE; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; CHILD; CHILD, PRESCHOOL; CIPROFLOXACIN; CONFIDENCE INTERVALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DYSENTERY, BACILLARY; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT; LOGISTIC MODELS; MALE; PROBABILITY; REFERENCE VALUES; SEVERITY OF ILLNESS INDEX; SHIGELLA DYSENTERIAE; TREATMENT OUTCOME;

EID: 0036901506     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/00006454-200212000-00010     Document Type: Article

References (24)

1. Bennish ML, Wojtyniak BJ. Mortality due to shigellosis: Community and hospital data. Rev Infect Dis 1991;13(Suppl 4):S245-51.
2. Nathoo KJ, Porteous JE, Siziya S, Wellington M, Mason E. Predictors of mortality in children hospitalized with dysentery in Harare, Zimbabwe. Cent Afr J Med 1998;44:272-6.
3. Kotloff KL, Winickoff JP, Ivanoff B, et al. Global burden of Shigella infections: Implications for vaccine development and implementation of control strategies. Bull World Health Organ 1999;77:651-66.
4. Ries AA, Wells JG, Olivola D, et al. Epidemic Shigella dysenteriae type 1 in Burundi: Panresistance and implications for prevention. J Infect Dis 1994;169:1035-41.
5. Nathoo KJ, Sanders JA, Siziya S, Mucheche C. Haemolytic uraemic syndrome following Shigella dysenteriae type 1 outbreak in Zimbabwe: A clinical experience. Cent Afr J Med 1995;41:267-74.
6. Rollins NC, Wittenberg DF, Coovadia HM, Pillay DG, Karas AJ, Sturm AW. Epidemic Shigella dysenteriae type 1 in Natal. J Trop Pediatr 1995;41:281-4.
7. Bennish ML, Harris JR, Wojtyniak BJ, Struelens M. Death in shigellosis: Incidence and risk factors in hospitalized patients. J Infect Dis 1990;161:500-6.
8. Salam MA, Bennish ML. Antimicrobial therapy for shigellosis. Rev Infect Dis 1991;13(Suppl 4):S332-41.
9. Bogaerts J, Verhaegen J, Munyabikali JP, et al. Antimicrobial resistance and serotypes of Shigella isolates in Kigali, Rwanda (1983 to 1993): Increasing frequency of multiple resistance. Diagn Microbiol Infect Dis 1997;28:165-71.
10. Bennish ML, Levy SB. Antimicrobial resistance of enteric pathogens. In: Blaser JM, Smith PD, Ravdin JI, Greenberg HB, Guerrant RL, eds. Infections of the Gastrointestinal Tract. New York: Raven Press, 1995:1499-523.
11. Bennish ML, Salam MA, Hossain MA, et al. Antimicrobial resistance of Shigella isolates in Bangladesh, 1983-1990: Increasing frequency of strains multiply resistant to ampicillin, trimethoprim-sulfamethoxazole, and nalidixic acid. Clin Infect Dis 1992;14:1055-60.
12. Processing and interpretation of bacterial fecal cultures. In: Isenberg HD, ed. Clinical Microbiology Procedures Handbook. vol 1. 1.10.1-1.10.25. Washington DC: American Society for Microbiology, 1992.
13. Rodary C, Com-Nougue C, Tournade MF. How to establish equivalence between treatment: A one-sided clinical trial in paediatric oncology. Stat Med 1989;5:593-8.
14. Salam MA, Dhar U, Khan WA, Bennish ML. Randomised comparison of ciprofioxacin suspension and pivmecillinam for childhood shigellosis. Lancet 1998;352:522-7.
15. Christ W, Lehnert T, Ulbrich B. Specific toxicologic aspects of the quinolones. Rev Infect Dis 1988;10(Suppl 1):S141-6.
16. Johnson RJ, Black WD, Sigler RE, Baragi VM, Gough AW. Evaluation of toxicokinetic variables and arthropathic changes in juvenile rabbits after oral administration of an investigational fluoroquinolone, PD 117596. Am J Vet Res 2000;61:1396-402.
17. Burkhardt JE, Walterspiel JN, Schaad UB. Quinolone arthropathy in animals versus children. Clin Infect Dis 1997;25:1196-204.
18. Hampel B, Hullmann R, Schmidt H. Ciprofloxacin in pediatrics: Worldwide clinical experience based on compassionate use: Safety report. Pediatr Infect Dis J 1997;16:127-9; discussion 160-2.
19. Khan WA, Seas C, Dhar U, Salam MA, Bennish ML. Treatment of shigellosis: V. Comparison of azithromycin and ciprofloxacin: A double-blind, randomized, controlled trial. Ann Intern Med 1997;126:697-703.
20. Mason PR, Nathoo KJ, Wellington M, Mason E. Antimicrobial susceptibilities of Shigella dysenteriae type 1 isolated in Zimbabwe: Implications for the management of dysentery. Cent Afr J Med 1995;41:132-7.
21. Karas JA, Pillay DG, Naicker T, Sturm AW. Laboratory surveillance of Shigella dysenteriae type 1 in KwaZulu-Natal. S Afr Med J 1999;89:59-63.
22. Salam MA, Bennish ML. Therapy for shigellosis. I. Randomized, double-blind trial of nalidixic acid in childhood shigellosis. J Pediatr 1988;113:901-7.
23. Chunder N, Bhattacharya SK, Biswas D, Niyogi SK, Kumar R. Isolation of a fluoroquinolone resistant Shigella dysenteriae 1 strain from Calcutta. Indian J Med Res 1997;106:494-6.
24. Ronsmans C, Islam T, Bennish ML. Medical practitioners' knowledge of dysentery treatment in Bangladesh. BMJ 1996;313:205-6.