PneumoniaISPOTNCT01386840
IndiaCLEN Multicentre Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children
A study testing Severe Pneumonia - Home Management in people with Pneumonia, run by Lata Medical Research Foundation, Nagpur at 6 sites in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Severe Pneumonia - Home Management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,118 participants
- Where
- 6 sitesIndia
- Study dates
- Jan 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh, Uttar Pradesh
Post Graduate Institute of Medical Sciences, Chandigarh
Chandigarh, Chandigarh
Institute of Child Health, Chennai
Chennai, Tamil Nadu
Indira Gandhi Govt. Medical College, Nagpur
Nagpur, Maharashtra, 440018
B.J. Medical College, Pune
Pune, Maharashtra
Mahatma Gandhi Institute of Medical Sciences, Sevagram
Wardha, Maharashtra
About this study
Official title: IndiaCLEN Multicentric Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children
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.
Read the detailed description
Primary objectives of this trial are to assess the rates of treatment failure (as defined below) within the first 7 days or efficacy of a 7 day course of oral amoxycillin when administered at home in comparison to administration of oral amoxycillin for first 48 hours in the hospital.
Treatment failure is defined as follows-
- Clinical deterioration of disease any time after enrollment: developing any sign of very severe disease such as persistent vomiting (vomiting repeated thrice within an hour due to any reason), central cyanosis, grunt, stridor, abnormally sleepy or difficult to wake, inability to drink, convulsions, or death.
- Change of antibiotic: due to persistent vomiting (vomiting of amoxycillin within 20 minutes of administration; 3 such attempts), or, developing a co-morbid condition, or persisting fever > 98.6°F with lower chest indrawing even after 3rd day, or, fever alone at or after day 5, or, lower chest indrawing alone (non responsive to three doses of nebulization with bronchodilator) at or after day 5(as reported by the mother), or, persistence of fast breathing after day 7 which is non responsive to three doses of nebulisation with bronchodilator.
- Hospitalization: any time in home managed patients or clinical decision to extend the hospitalization longer than 48 hours in hospitalized children or re-hospitalization in those discharged after 48 hours from hospital. It could be related to pneumonia, or to therapy with amoxycillin [relatedness determined by the Data \& Safety Monitoring Board (DSMB)].
- Children who need to restart antibiotics i.e. "failure of treatment", between day 8th and day 14th due to reappearance of any danger signs, lower chest indrawing or fast breathing which is non responsive to three trials of nebulization with bronchodilator.
- Serious adverse event considered possibly or probably related to amoxycillin.
- Left against medical advice (LAMA) or Voluntary withdrawal of consent from study from enrollment uptill day 14th.
- Loss to follow up uptill day 14th.
Secondary objectives of this trial are to determine in children receiving oral amoxycillin for severe pneumonia, the following:
- Determine the proportion of children who need to restart antibiotics i.e. "failure of treatment", between day 8th and day 14th due to reappearance of any danger signs, lower chest indrawing or fast breathing which is non responsive to three trials of nebulization with bronchodilator.
- To identify clinical predictors at baseline and during the course of treatment that predicts "failure of oral treatment", from enrollment till day 14th.
- The costs of home and hospital management of severe pneumonia with oral amoxycillin.
- Left against medical advice (LAMA) or Voluntary withdrawal of consent from day 7th to day 14th.
- Loss to follow up from day 8th to day 14th.
- Conditions
- Pneumonia
- Being tested
- Severe Pneumonia - Home Management
- Keywords
- Efficacy of Treatment, Severe, home treatment, treatment at hospital
- Medical subject headings
- Pneumonia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe Pneumonia - Home ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Severe Pneumonia - Hospital Management | No intervention | 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" |
| Severe Pneumonia - Home Management | Experimental | 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. Receives: Other: Severe Pneumonia - Home Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of a 7 day course of oral amoxycillin when administered at Home in comparison to administration of oral amoxycillin for first 48 hours in the hospital
Primary outcomes are to assess the efficacy of a 7 day course of oral amoxycillin when administered at home in comparison to administration of oral amoxycillin for first 48 hours in the hospital, on the following study outcomes, the presence of any one of which indicate "failure of treatment" :
- Clinical deterioration of disease any time after enrollment
- Change of antibiotic
- Hospitalization
- Serious adverse event considered possibly or probably related to amoxycillin.
- Left against medical advice (LAMA)
- Loss to follow up on day 8th
Measured: Day of enrollment to Day 7
Secondary outcomes (1)
To determine factors leading to treatment failure from day 8 to day 14 and costs of home and hospital management of severe pneumonia with oral amoxycillin
Secondary outcome of this trial are to determine the following:
- Determine the proportion of children who need to restart antibiotics i.e. "failure of treatment", between day 8th and day 14th due to reappearance of any danger signs, lower chest indrawing or fast breathing
- To identify clinical predictors at baseline and during the course of treatment that predicts "failure of oral treatment",
- The costs of home and hospital management of severe pneumonia with oral amoxycillin.
- Left against medical advice (LAMA)
- Loss to follow up from day 8th to day 14th.
Measured: Day 8 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lata Medical Research Foundation, Nagpur
- Sponsor type
- University, hospital or other
- Collaborators
- Indira Gandhi Medical College, Shimla, International Clinical Epidemiology Network (INCLEN) TRUST, MCH-STAR Initiative, India
- Responsible party
- Principal investigator, Dr.Archana B Patel, Lata Medical Research Foundation, Nagpur
- Investigators
- Archana B Patel, MD,DNB,PhD, Principal investigator, Professor And Head, Pediatrics, Indira Gandhi Govt. Medical College & CEO and Vice President, Lata MEdical Research Foundation, Nagpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386840
- Sponsor's protocol ID
- 02_ISPOT
- Acronym
- ISPOT
- Status last verified
- May 2015
- First submitted
- 25 Jun 2011
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patel 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.
PubMed 26577943
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IndiaCLEN Multicentric Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children
- ClinicalTrials.gov ID
- NCT01386840
- Acronym / sponsor ID
- ISPOT / 02_ISPOT
- Conditions
- Pneumonia
- Keywords
- Efficacy of Treatment, Severe, home treatment, treatment at hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,118 participants (actual)
- Lead sponsor
- Lata Medical Research Foundation, NagpurUniversity, hospital or other
- Collaborators
- Indira Gandhi Medical College, Shimla, International Clinical Epidemiology Network (INCLEN) TRUST, MCH-STAR Initiative, India
- Study start
- Jan 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary objectives of this trial are to assess the rates of treatment failure (as defined below) within the first 7 days or efficacy of a 7 day course of oral amoxycillin when administered at home in comparison to administration of oral amoxycillin for first 48 hours in the hospital.
Treatment failure is defined as follows-
- Clinical deterioration of disease any time after enrollment: developing any sign of very severe disease such as persistent vomiting (vomiting repeated thrice within an hour due to any reason), central cyanosis, grunt, stridor, abnormally sleepy or difficult to wake, inability to drink, convulsions, or death.
- Change of antibiotic: due to persistent vomiting (vomiting of amoxycillin within 20 minutes of administration; 3 such attempts), or, developing a co-morbid condition, or persisting fever > 98.6°F with lower chest indrawing even after 3rd day, or, fever alone at or after day 5, or, lower chest indrawing alone (non responsive to three doses of nebulization with bronchodilator) at or after day 5(as reported by the mother), or, persistence of fast breathing after day 7 which is non responsive to three doses of nebulisation with bronchodilator.
- Hospitalization: any time in home managed patients or clinical decision to extend the hospitalization longer than 48 hours in hospitalized children or re-hospitalization in those discharged after 48 hours from hospital. It could be related to pneumonia, or to therapy with amoxycillin [relatedness determined by the Data \& Safety Monitoring Board (DSMB)].
- Children who need to restart antibiotics i.e. "failure of treatment", between day 8th and day 14th due to reappearance of any danger signs, lower chest indrawing or fast breathing which is non responsive to three trials of nebulization with bronchodilator.
- Serious adverse event considered possibly or probably related to amoxycillin.
- Left against medical advice (LAMA) or Voluntary withdrawal of consent from study from enrollment uptill day 14th.
- Loss to follow up uptill day 14th.
Secondary objectives of this trial are to determine in children receiving oral amoxycillin for severe pneumonia, the following:
- Determine the proportion of children who need to restart antibiotics i.e. "failure of treatment", between day 8th and day 14th due to reappearance of any danger signs, lower chest indrawing or fast breathing which is non responsive to three trials of nebulization with bronchodilator.
- To identify clinical predictors at baseline and during the course of treatment that predicts "failure of oral treatment", from enrollment till day 14th.
- The costs of home and hospital management of severe pneumonia with oral amoxycillin.
- Left against medical advice (LAMA) or Voluntary withdrawal of consent from day 7th to day 14th.
- Loss to follow up from day 8th to day 14th.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe Pneumonia - Hospital Management | No intervention | –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" |
| Severe Pneumonia - Home Management | Experimental | Other: Severe Pneumonia - Home ManagementFor 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. |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Severe Pneumonia - Home ManagementFor 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. | Other | Severe Pneumonia - Home Management |
Primary outcome
To assess the efficacy of a 7 day course of oral amoxycillin when administered at Home in comparison to administration of oral amoxycillin for first 48 hours in the hospital
Time frame: Day of enrollment to Day 7
Primary outcomes are to assess the efficacy of a 7 day course of oral amoxycillin when administered at home in comparison to administration of oral amoxycillin for first 48 hours in the hospital, on the following study outcomes, the presence of any one of which indicate "failure of treatment" : * Clinical deterioration of disease any time after enrollment * Change of antibiotic * Hospitalization * Serious adverse event considered possibly or probably related to amoxycillin. * Left against medical advice (LAMA) * Loss to follow up on day 8th
1 secondary outcome
To determine factors leading to treatment failure from day 8 to day 14 and costs of home and hospital management of severe pneumonia with oral amoxycillin
Time frame: Day 8 to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
- Derived from this study: PubMed 26577943Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Archana B Patel, MD,DNB,PhD principal investigator
Professor And Head, Pediatrics, Indira Gandhi Govt. Medical College & CEO and Vice President, Lata MEdical Research Foundation, Nagpur
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Severe Pneumonia - Home Management in people with Pneumonia, run by Lata Medical Research Foundation, Nagpur at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of a 7 day course of oral amoxycillin when administered at Home in comparison to administration of oral amoxycillin for first 48 hours in the hospital (time frame: Day of enrollment to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01386840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.