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o The O1 serogroup have caused the majority of cholera outbreaks and
are subdivided in to two biotypes:

² Classical
² El Tor: relatively mild and asymptomatic.

This biotype produces hemolysins (exotoxins that lyse red blood cells).

      
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o Dp until the beginning of the 20th century all strains had been classical.

o The 7th Pandemic began in Indonesia and devastated the Philippines.

o Strain was not classical it was the El Tor Strain.

o The El Tor strain is more dangerous because the duration of carriage
after infection is longer in the El Tor Strain.

o El Tor also survives for longer periods of time in the extraintestinal
environment than does the classical strain.
  
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o The El Tor has evolved into an even more dangerous strain.
o In 1992, people in Bangladesh were affected by a large cholera
epidemic.
o The strain of cholera was comparable to El Tor but its antigenic
structure changed.
o There are no existing immunities.
o The strain was called O139 ´Bengalµ

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o 180 children

² between 2-12 years,
² having watery diarrhea for ”24 hr and
² severe dehydration,
² who tested positive for Vibrio cholerae by hanging drop
examination or culture of stool 

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o Children with severe undernutrition (weight for age less than 60% of
50th percentile of CDC 2000 standards)

o Coexisting systemic illness

o Blood in stool

o Received an antibiotic/antidiarrheal within preceding 24 hours

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o 9 + 5

² name, age, address, telephone number

² Occupation, education and monthly income of parents

² duration of illness, frequency of diarrhea and vomiting prior to
admission, and

² presence of associated symptoms including abdominal pain,fever,
and abdominal distension(
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o Evaluation was done for general hygiene, vitals, and signs of dehydration

o The present weight was recorded on a standardized weighing scale to the
nearest 0.5 kg.

o Height was measured to the nearest 0.1 cm.

o The same observer obtained all the measurements

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o Eligible children were allotted a study number.

o These numbers corresponded to the order of patients entering the trial.

o Children were randomized to receive a single dose of
oral azithromycin (20 mg/kg) or ciprofloxacin (20 mg/kg).

o A simple randomization was done using a computer generated random
number table on a master list(
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o Allocation of the treatment group was concealed by having the names of
both the study drug stored in identical sealed envelope, which were
opened after a patient had been enrolled in the study and assigned a study
number.

o Randomized children were immediately rehydrated with intravenous
Ringer·s lactate solution 30 mL/kg in first ½ hour followed by 70 mL/kg
over next 2½ hours.

o A stool sample was obtained for hanging drop examination and culture for
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as soon as the child passed stools after admission.

o The patient was reassessed for hydration after 3-4 hours and managed
further as per the WHO Guidelines. Œ
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o The assigned Study drug was orally administered after initial rehydration,
under supervision.

o Eligible subjects received either a single dose of azithromycin (20 mg/kg)
or ciprofloxacin (20 mg/kg).

o Both the drugs were available in 100 mg, 250 mg and 500 mg tablets and
the dose was rounded to nearest 50 mg.

o The dose was repeated if the child vomited within 10 minutes of drug
administration.
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o Each Study day was defined as 24 hour counted from the administration of
study drug.

o Children remained in the Study center for 72 hours (day 3) or until
resolution of watery diarrhea, whichever was later.

o The parents were asked to bring their child back for a follow-up visit on
day 7.

o If the patient failed to return on the follow-up visit, the parents were
contacted by telephone and asked to come on the next day.

o Clinical monitoring was performed on multiple occasions on the day of
admission and subsequently at the end of day 1, 2, 3 and 7. 2
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o A record was kept of frequency of stool and vomiting for every 24 hrs.

o The amount of intravenous fluid and ORS administered was also
recorded at the end of each Study day.

o A stool sample or rectal swab was obtained at the end of day 1, 2, 3 and
at follow-up visit (day 7).

o Authors also noted for any possible adverse effects of the drug
administered like hypersensitivity reaction, phototoxicity, tendinopathy
and joint pain or swelling.

     

 

o The motility of u  was seen by hanging drop preparation.

o Stool sample was transported in alkaline peptone water or Cary Blair
media and processed.

o The stool samples were cultured in bile salt agar, MacConkey agar and
thiosulphate citrate bile sucrose agar

o Plates were incubated at 37ºC for 24 hours

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o The samples were inoculated in fresh alkaline peptone water for
enrichment and subseqent plating

o Bacteriological analysis was done by standard laboratory techinques and
u  isolates were serotyped by slide agglutination test using
specific antisera (Denca Saken).

o Antimicrobial susceptibility testing of the strains was performed by
standard methods.


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o Data were analysed using SPSS version 13.0.

o All quantitative variables (between the groups) were compared by
unpaired -test; categorical variables were compared by Chi-square test
or Fisher·s exact test.

o îÈ0.05 was considered as significant.

o Variables which were measured repeatedly were analysed with repeated
measure ANOVA at 1% level of significance to allow for multiple
comparisons


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