Severe pneumonia Respiratory Influenza and pneumonia
Conditions
Interventions
For the primary end-point, a total of two looks at the data would require 1,182 patients (591 in each group) to be studied. This sample size assumes a study power of 80% to look for differences betwe
Sponsors
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 5 - 59 months 2. History of cough or difficult breathing 3. Central cyanosis or inability to drink 4. Caretaker is willing to sign informed consent form
Exclusion criteria
Exclusion criteria: 1. Current illness greater than 10 days old 2. Past history of more than two wheezing episodes or diagnosed asthma 3. Known cardiac patient 4. Known Human Immunodeficiency Virus (HIV) infected 5. Known family member to be HIV infected 6. More than 24 hours hospitalisation within the last 7 days 7. History of severe adverse reaction to study drugs 8. Prior enrolment in the study 9. Injection of antibiotic more than 24 hours prior to enrolment 10. Stridor 11. Known renal failure or not passed urine in last 24 hours 12. Cerebral malaria 13. Bacterial meningitis 14. Clinical jaundice 15. Oral thrush 16. Hepatosplenomegaly 17. Follow-up to home not possible
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment failures, as defined above, 48 hours after randomisation 2. Treatment failures, as defined above, 11 days after randomisation 3. Treatment failures, as defined above, 21 - 30 days after randomisation (if a patient develops signs given for treatment failure within two weeks after stopping treatment it will be considered a relapse) 4. Deaths by 21 ? 30 days after randomisation 5. Bacterial pathogens isolated in blood cultures from children with very severe pneumonia 6. Antimicrobial susceptibility in blood culture isolates from children with very severe pneumonia | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is "treatment failure at day 6" defined as follows: 1. If at any time after randomisation the following occur: 1.1. Death 1.2. Development of bacterial meningitis, empyema, septic shock or renal failure 1.3. Serious adverse events leading to change of therapy or any modification of antibiotic therapy before day 6 (modification of the dosage of the antibiotic will not be considered as a "treatment failure") 1.4. Left Against Medical Advice (LAMA), or withdrawal of consent (reason of including this in treatment failure is because parents may LAMA or withdraw the consent thinking their child is not improving on the study treatment), or loss to follow-up OR 2. Development of any of the two signs at 48 hours after randomisation: 2.1. Worsening of tachypnoea (defined as 20 breaths above baseline), or 2.2. Development/persistence of abnormal sleepiness or difficulty in awakening, or 2.3. Development/persistence of inability to drink OR 3. Development of two or more of the following at Day 6 after randomisation: 3.1. Worsening of tachypnoea (defined as 20 breaths above baseline, or 3.2. Development/persistence of abnormal sleepiness or difficulty in awakening, or 3.3. Development/persistence of inability to drink | — |
Countries
Bangladesh, Ecuador, India, Mexico, Pakistan, Viet Nam, Yemen, Zambia
Outcome results
None listed