Clinical trial · Interventional
IndiaCLEN Multicentre Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children
IndiaCLEN Multicentric Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children
NCT01386840CI-TRIAL-00017936ISPOTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and efficacy of oral amoxicillin in treating WHO defined severe pneumonia(cough and fast breathing with lower chest indrawing) at home and at hospital using an open labelled multicentric prospective two-arm randomized clinical trial to determine the differences in failure of treatment with a 7 day course of oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent home after enrolment, in children 3 to 59 months old who have severe pneumonia. The investigators developmental hypothesis were to test whether the community/home based oral amoxicillin is efficacious for treating severe pneumonia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pneumonia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Severe Pneumonia - Home Management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Severe Pneumonia - Hospital Management
- description
- Those randomized to hospital management will be monitored by health personnel for at least 48 hours for clinical deterioration and parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, Clinical deterioration, Other signs eg. comorbid conditions, Assessment of adherence, Adverse event. Mothers, whose children are discharged after 48 hours, will be counseled to continue with oral treatment prescribed for a period of 7 days and will be advised to return to healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the "patient discharge counselling checklist". Mothers will be given a "study patient data card"
- type
- EXPERIMENTAL
- label
- Severe Pneumonia - Home Management
- description
- For those randomized to home management, first dose will be administered by the mother/caretaker under supervision at health facility. The health personnel will assess the parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, clinical deterioration, Other signs eg. co-morbid conditions, Assessment of adherence, Adverse event when they visit the home after 24 hours, 72 hours and on day 8th. Mothers will be advised to return to the healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the "patient discharge counselling checklist". Mothers will be given a "study patient data card" with contact Numbers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 59 Months
Show eligibility criteria text
Inclusion Criteria: * Children aged 3 to 59 months with pneumonia and lower chest wall indrawing * Ability to take orally * Absence of radiological consolidation or effusion * Informed consent by a legal guardian Exclusion Criteria: Children with any of the following conditions: * Very severe pneumonia/disease * Respiratory rate \> 70/min * Persistent vomiting * Known prior episodes of asthma, or, three or more prior episodes of wheezing * LCI that resolves after three doses of bronchodilator therapy1 * Documented use of prior oral antibiotics for 48 hours * Severe malnutrition (weight for height \< 3SD or kwashiorkor) * Known penicillin or amoxicillin allergy * Hospitalization in the last two weeks * Known or clinically recognizable HIV, congenital cardiac or respiratory anomalies, chronic lung disease including bronchopulmonary dysplasia, neurological impairment that affects respiratory function, renal diseases, malignant or haematological diseases. * Other diseases requiring antibiotic therapy at presentation, such as meningitis,dysentery, osteomyelitis, septic arthritis, evident tuberculosis, etc. * Anaemia requiring blood transfusion * Kerosene poisoning * Measles in the last 15 days * Previous inclusion in the study or already included in another study * Living outside a pre-defined area * Parental or caretaker refusal to participate in the study
References
Publications (1)
- DERIVEDPatel AB, Bang A, Singh M, Dhande L, Chelliah LR, Malik A, Khadse S; ISPOT Study Group. A randomized controlled trial of hospital versus home based therapy with oral amoxicillin for severe pneumonia in children aged 3 - 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study. BMC Pediatr. 2015 Nov 17;15:186. doi: 10.1186/s12887-015-0510-9. PMID 26577943