Double‐blind, randomized clinical trial for safety and efficacy of norfloxacin for shigellosis in children

Sk, Bhattacharya; Mk, Bhattacharya; Dutta, D; M, Deb; Das, K. P.; Koley, Hemanta; Nair, G. Balakrish

doi:10.1111/j.1651-2227.1997.tb08898.x

Cited by 28 publications

(9 citation statements)

References 7 publications

(4 reference statements)

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“…48 Gentamicin was found to be bacteriologically but not clinically inferior to nalidixic acid; 52 however, norfloxacin was clinically superior to nalidixic acid. 47 One study showed that cefixime was clinically superior to ampicillin plus sulbactam, 51 and another study showed that co-trimoxazole had better clinical, but not bacteriological, outcomes than ampicillin. 63 Finally, one study 45 reported that pivmecillinam was clinically and bacteriologically superior to nalidixic acid when cases with Shigella infections that are resistant to nalidixic acid were included.…”

Section: Resultsmentioning

confidence: 99%

Identification and management of Shigella infection in children with diarrhoea: a systematic review and meta-analysis

Tickell

Brander

Atlas

et al. 2017

The Lancet Global Health

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SummaryBackgroundShigella infections are a leading cause of diarrhoeal death among children in low-income and middle-income countries. WHO guidelines reserve antibiotics for treating children with dysentery. Reliance on dysentery for identification and management of Shigella infection might miss an opportunity to reduce Shigella-associated morbidity and mortality. We aimed to systematically review and evaluate Shigella-associated and dysentery-associated mortality, the diagnostic value of dysentery for the identification of Shigella infection, and the efficacy of antibiotics for children with Shigella or dysentery, or both.MethodsWe did three systematic reviews (for mortality, diagnostic value, and antibiotic treatment of Shigella and dysentery), and meta-analyses where appropriate, of studies in resource-limited settings. We searched MEDLINE, Embase, and LILACS database for studies published before Jan 1, 2017, in English, French, and Spanish. We included studies of human beings with diarrhoea and accepted all study-specific definitions of dysentery. For the mortality and diagnostic value searches, we excluded studies that did not include an effect estimate or data necessary to calculate this estimate. The search for treatment included only randomised controlled trials that were done after Jan 1, 1980, and assessed antibiotics in children (aged <18 years) with dysentery or laboratory-confirmed Shigella. We extracted or calculated odds ratios (ORs) and 95% CIs for relative mortality and did random-effects meta-analysis to arrive at pooled ORs. We calculated 95% CIs assuming a binomial distribution and did random-effects meta-regression of log-transformed sensitivity and specificity estimates for diagnostic value. We assessed the heterogeneity of papers included in these meta-analyses using the I2 statistic and evaluated publication bias using funnel plots. This review is registered with PROSPERO (CRD42017063896).Findings3649 papers were identified and 60 studies were included for analyses: 13 for mortality, 27 for diagnostic value, and 20 for treatment. Shigella infection was associated with mortality (pooled OR 2·8, 95% CI 1·6–4·8; p=0·000) whereas dysentery was not associated with mortality (1·3, 0·7–2·3; p=0·37). Between 1977 and 2016, dysentery identified 1·9–85·9% of confirmed Shigella infections, with sensitivity decreasing over time (p=0·04). Ten (50%) of 20 included antibiotic trials were among children with dysentery, none were placebo-controlled, and two (10%) evaluated antibiotics no longer recommended for acute infectious diarrhoea. Ciprofloxacin showed superior microbiological, but not clinical, effectiveness compared with pivmecillinam, and no superior microbiological and clinical effectiveness compared with gatifloxacin. Substantial heterogeneity was reported for meta-analyses of the Shigella-associated mortality studies (I2=78·3%) and dysentery-associated mortality studies (I2=73·2%). Too few mortality studies were identified to meaningfully test for publication bias. No evidence of publication bi...

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Section: Resultsmentioning

confidence: 99%

Identification and management of Shigella infection in children with diarrhoea: a systematic review and meta-analysis

Tickell

Brander

Atlas

et al. 2017

The Lancet Global Health

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“…Despite this, fluoroquinolones were extensively used for the treatment of shigellosis, as these drugs provide more effective care [47][48][49]. During mid-2002, outbreaks of dysentery due to S. dysenteriae type 1 were reported [50,51].…”

Section: Discussionmentioning

confidence: 98%

Species diversity and antimicrobial resistance of Shigella spp. isolated between 2001 and 2004 from hospitalized children with diarrhoea in Kolkata (Calcutta), India

et al. 2005

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The incidence, phenotypic characteristics and antimicrobial resistance patterns of 193 Shigella strains isolated from 2489 hospitalized children with acute diarrhoea were studied during January 2001 to August 2004. S. flexneri (60%) was the most prevalent serogroup, followed by S. sonnei (23.8%), S. dysenteriae (9.8%) and S. boydii (5.7%). Since 2002, S. flexneri 2a was the most dominant serotype. Almost all S. flexneri strains exhibited resistance to ampicillin, co-trimoxazole, tetracycline, nalidixic acid and fluoroquinolones. After a lapse of almost 14 years, S. dysenteriae type 1 strains reemerged for the first time during 2002 and these strains were resistant to more than two antibiotics (multidrug resistance), including fluoroquinolones. An upsurge of similar resistance patterns was also noted among S. flexneri type 2a since December 2003. Resistance to fluoroquinolone increased year on year among S. dysenteriae type 1 and S. flexneri, but not in S. boydii or S. sonnei. Monitoring of antimicrobial susceptibility through a surveillance programme is recommended to select appropriate antibiotics for the effective treatment of shigellosis in this region.

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“…Clinical studies have underlined their safe use in adults and children (Bhattacharya et al, 1997;Salam et al, 1998). In this study, 30 % of the Shigella strains were resistant to fluoroquinolones and a S. boydii serotype 1 strain (G24371) was resistant to each of the four compounds tested (Table 2).…”

Section: Fluoroquinolone Resistance and Resistance Mechanismsmentioning

confidence: 90%

Molecular characterization of multidrug-resistant Shigella species isolated from epidemic and endemic cases of shigellosis in India

Pazhani

Niyogi

Singh

et al. 2008

Journal of Medical Microbiology

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Shigella species represent one of the growing numbers of antimicrobial-resistant bacteria in developing countries. Fluoroquinolone-resistant strains of Shigella dysenteriae type1 and Shigella flexneri type 2a emerged in India during 2002 and 2003, respectively. Sixty strains of Shigella from different parts of India were analysed for antimicrobial susceptibility, the presence of the qnr plasmid, mutations in the quinolone resistance determining regions (QRDRs), fluoroquinolone accumulation, and the presence of other genes encoding resistance to various antimicrobials. Fluoroquinolone-resistant strains had mutations in gyrA and parC genes and had an active efflux system. They were also resistant to several other antimicrobials but were susceptible to azithromycin and ceftriaxone. The majority of the strains harboured genes encoding resistance to ampicillin (97 %), tetracycline (95 %), streptomycin (95 %) and chloramphenicol (94 %). PFGE analysis revealed clonality among strains of S. dysenteriae types 1 and 5, S. flexneri type 2a and Shigella boydii type 12. INTRODUCTIONShigellosis remains an important public health problem in developing countries with Shigella sonnei in Europe and the US and Shigella flexneri in Asian and African countries being of epidemiological importance. Antimicrobial therapy is advocated for shigellosis to shorten the duration of illness (Salam & Bennish, 1991). However, in Asia and Africa, antimicrobial resistance is an emerging problem among Shigella species (von Seidlein et al., 2006) and treatment options are becoming limited globally (Salam & Bennish, 1991;Kariuki & Hart, 2001). The World Health Organization has recommended that ciprofloxacin should be considered a first-line antibiotic for the treatment of shigellosis, and the use of nalidixic acid is not encouraged, even in areas where it is still effective against Shigella (WHO, 2004). Similar to the prevalence of different serotypes, antimicrobial-resistance patterns of strains also differ from country to country and even within the same country (Pazhani et al., 2005;von Seidlein et al., 2006), which may be due to the spread of resistant clones as found for multidrug-resistant strains of Shigella dysenteriae type 1 in eastern parts of India (Pazhani et al., 2004). In this study, we have investigated the mechanisms of antibiotic resistance and clonal relatedness of Shigella strains isolated from epidemic and endemic cases of shigellosis in different parts of India. METHODSBacterial strains. We examined 60 strains of Shigella species (20 S. dysenteriae, 16 S. flexneri, 7 Shigella boydii and 17 S. sonnei) isolated from dysentery outbreaks from different parts of India and sporadic hospitalized cases of shigellosis in Kolkata and Goa between 2001 and 2004. Strains were confirmed as Shigella spp. by standard biochemical tests (WHO, 1987) and serotyped using commercially available antisera (Denka Seiken).Antimicrobial susceptibility testing. Antimicrobial susceptibility tests were performed by a disc diffusion method in accordance with...

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Double‐blind, randomized clinical trial for safety and efficacy of norfloxacin for shigellosis in children

Cited by 28 publications

References 7 publications

Identification and management of Shigella infection in children with diarrhoea: a systematic review and meta-analysis

Identification and management of Shigella infection in children with diarrhoea: a systematic review and meta-analysis

Species diversity and antimicrobial resistance of Shigella spp. isolated between 2001 and 2004 from hospitalized children with diarrhoea in Kolkata (Calcutta), India

Molecular characterization of multidrug-resistant Shigella species isolated from epidemic and endemic cases of shigellosis in India

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