Multicentre randomised clinical study to compare the efficacy of chloramphenicol with that of ampicillin plus gentamicin in children aged 2 to 59 months with very severe pneumonia: multicentre study conducted in Bangladesh, India, Mexico, Pakistan, Yemen, Vietnam, and Zambia

Completed

• Conditions: Severe pneumonia; Respiratory; Influenza and pneumonia

• Registration Number: ISRCTN39543942
• Lead Sponsor: The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1182

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified