FURAZOLIDONE VS CIPROFLOXACIN IN THE TREATMENT OF MILD OR MODERATE DYSENTERY IN CHILDREN UNDER 5 YEARS OLD: A SINGLE BLIND, RANDOMIZED CLINICAL TRIAL OF NON-INFERIORITY.
- Registration Number
- PER-097-11
- Lead Sponsor
- IVERSIDAD PERUANA CAYETANO HEREDIA, Instituto Nacional de Salud del Niño,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 7
• EVERY PATIENT TO BE INCLUDED IN THIS STUDY IS OVER 12 MONTHS AND UNDER 5 YEARS (60 MONTHS) OF AGE, WITH THIS PICTURE OF MILD DYSENTERY (AQUEOUS DIARRHEA WITH FEVER AND PRESENCE OF RED CELLS AND PLATELETS> 50 FOR FIELD) OR MODERATE DYSENTERY 72hrs OR LESS DURATION AND GO TO BE ATTENDED IN HOSPITALS SELECTED FOR THE STUDY.
• CHILDREN WITH A PREVIOUS DIAGNOSIS OF CONDITIONS TO BE CONSIDERED CONTRAINDICATIONS FOR TREATMENT WITH FURAZOLIDONE, SUCH AS LACK OF GLUCOSE 6 PHOSPHATE DEHYDROGENASE, HEMOLYTIC ANEMIA RELATED TO G6PD AND KINASE PYRUVATE DEFICIENCY.
• CHILDREN COMORBIDITIES BACKGROUND AFFECTING THE IMMUNE STATE AND THEN THE CLINIC (INFECTION WITH HIV, AIDS; CHRONIC DISEASES: LIVER, KIDNEY, HEART, KIDNEY FAILURE, SEVERE MALNUTRITION).
• CHILDREN KNOW THAT HAS RECEIVED DIPHENOXYLATE HYDROCHLORIDE THERAPY WITH ATROPINE OR LOPERAMIDE, BECAUSE OF THE RISK OF EXTENDING DISEASE.
• CHILDREN WITH PRIOR ALLERGIC OR HYPERSENSITIVITY TO FLUOROQUINOLONES OR OTHER DERIVATIVES OF QUINOLONES.
• CHILDREN WITH TENDINITIS BACKGROUND OR BREACH OF TENDON, CENTRAL NERVOUS SYSTEM DISORDERS INCLUDING CEREBRAL ATHEROSCLEROSIS, EPILEPSY, OR OTHER FACTORS THAT PREDISPOSE TO SEIZURE.
• CHILDREN THAT HAVE RECEIVED ANY DOSE OF ANTIBIOTICS IN THE LAST 72 HOURS DURING THE CURRENT CLINICAL CONDITION.
• PATIENTS WHOSE PARENTS refuse to PARTICIPATE IN THE STUDY OR NOT SIGN THE INFORMED CONSENT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method