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National Consultation on
Childhood ARI Case Management:
Translating Research to
Policy and Program
Proceedings Report
National Consultation on
Childhood ARI Case Management:
Translating Research to
Policy and Program
New Delhi
February 25, 2009
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PREFACE
The burden of childhood pneumonia, particularly in India, is undeniably and unacceptably
high. Preventing children from contracting pneumonia is essential for reducing child deaths. Key
prevention measures include promoting exclusive breastfeeding and appropriate complementary
feeding, improving immunization rates, reducing indoor air pollution, etc. Recognition of the
signs and symptoms of pneumonia at the peripheral level, coupled with an equitable and timely
access to a full-course of appropriate antibiotic therapy are life-saving measures. Because
pneumonia kills more children than any other illness, any effort to improve overall child survival
must address the reduction of pneumonia-related death toll on a priority basis.
Globally, and at the national level, a number of research studies are yielding evidence for
improving the case management of childhood acute respiratory infections. This report
summarizes the discussions from a technical consultation organized by IndiaCLEN, with support
from USAID’s MCH-STAR initiative to share the latest evidence on ARI case management so as to
inform program and policy. The technical consultation draws upon the collective technical and
programmatic wisdom of researchers, policymakers, program managers and academics to review
the available research findings in light of the existing policy framework and technical guidelines.
USAID/India and MCH-STAR are committed to supporting efforts that contribute to evidence-
based policy development and dialogue. We hope that the discussions and conclusions from
this meeting will play a useful role in identifying a research agenda for the country on ARI case
management. We also hope that this consultation will facilitate the development of a coalition to
play a sustained leadership role through research and dialogue for reducing pneumonia-related
deaths among children in our country.
iii
Contents
Acronyms 4
I. Background 6
II. Proceedings 7
Introductory Session 7
Annex 1
IV. Agenda 18
Annex 2
V. Participants 19
v
Acronyms
CEU Clinical Epidemiology Network
CSSM Child Survival and Safe Motherhood Programme
Hib Haemophilus influenzae Type B (vaccine)
IAP Indian Academy of Pediatrics
IndiaCLEN India Clinical Epidemiology Network
IPEN IndiaCLEN Program Evaluation Network
ISCAP IndiaCLEN Short Course Amoxicillin Therapy for Pneumonia
MDGs Millennium Development Goals
NNF National Neonatology Forum
NSP Non-severe pneumonia
UIP Universal Immunization Programme
IMNCI Integrated Management of Neonatal and Childhood Illnesses
USAID United States Agency for International Development
WHO World Health Organization
UNICEF United Nations Children’s Fund
MCH-STAR Maternal Child Health Sustainable Technical Assistance
and Research Initiative
APPIS Amoxicillin Penicillin Pneumonia International Study
NO-SHOTS New Outpatient Short- Course Home Oral Therapy
for Severe Pneumonia
SPEAR Severe Pneumonia Evaluation Antimicrobial Research
SAPNA South Asian Pneumococcal Alliance
IBIS Invasive Bacterial Infections Surveillance
EAG Empowered Action Group
CIHD Centre for International Health and Development
ANM Auxiliary Nurse Midwife
AWW Anganwadi Worker
RCH Reproductive and Child Health
ASHA Accredited Social Health Activist
vi
I. Background
World over, pneumonia kills more children sepsis in neonates, and the co-existence of
than AIDS, malaria and measles combined several morbidities leading to a single death,
together, states a report `Pneumonia – The etc.
Forgotten Killer of Children,’ brought out
by the United Nations Children’s Fund In India, ARIs contribute to approximately
(UNICEF) and World Health Organization 40% of all childhood illnesses in India, and
(WHO). The incidence in this age group is six approximately 30% of all childhood deaths.
times higher in developing countries (0.29 A number of research studies and pilots
episodes per child per year) as compared to have been conducted or are underway that
the developed countries (0.05 episodes per can provide strong scientific evidence for
child per year). This translates into about 156 the modification and improvement of case
million new episodes each year worldwide, management of ARIs in children, and thereby
of which 151 million episodes are in the save children’s lives. The India Clinical
developing world. India ranks first in the list, Epidemiology Network (IndiaCLEN), with
with around 43 million cases followed by assistance from USAID’s Maternal and Child
China (21 million) and Pakistan (10 million)1. Health Sustainable Technical Assistance and
However, of all the cases, only around 7–13% Research (MCH-STAR) Initiative, organized
are severe enough to be life-threatening and a National Consultation on Childhood ARI
require hospitalization. Substantial evidence Management: Translating Research into
also reveals that the leading risk factors Policy and Programme, in Delhi on February
contributing to pneumonia incidence are lack 25, 2009 to deliberate on the latest policy-
of exclusive breastfeeding, undernutrition, relevant evidence on childhood ARI in India
indoor air pollution, low birth weight, and globally.
crowding and lack of measles immunization.
The objectives of the national consultation
While estimates say that pneumonia has were:
been the single leading cause of childhood • To share the latest research findings
mortality, there is conflicting evidence for pertaining to ARI case management
effective childhood acute respiratory infection • To identify and build consensus on
(ARI) case management, pertaining to large specific research findings with policy and
differences in case definition of pneumonia program implications
between studies, low specificity of verbal • To develop a roadmap for incorporating
autopsies in community-based studies, specific research findings into the policy
difficulties in distinguishing pneumonia from framework.
1
Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and etiology of childhood pneumonia. Bull World
Health Organ. 2008;86:408–16
1
II. Proceedings
2
Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and Etiology of Childhood Pneumonia. Bull World
Health Organ. 2008;86:408–16
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National Consultation on Childhood ARI Case Management: Translating Research to Policy and Program
determine the best approach for ARI case Pneumonia Case Management
management, it is necessary to accept the Guidelines: Evidence from
available global evidence and contextualize Multi-centric Studies
it within the prevailing diversity of India.
He also stressed that the countdown for the Dr. Ashok Patwari, Research Professor in
Millennium Development Goals (MDGs) has International Health at the School of Public
already begun, and there is an urgent need to Health in Boston University (BU) and Senior
move rapidly to achieve them. He highlighted Technical Advisor with MCH-STAR Initiative,
that every fifth child dies of pneumonia, briefed about the engagement of the Centre
which calls for refinement of the existing for International Health and Development
policies and an increased program thrust.
4
Proceedings
1141-48) to address the question of “Can The third issue he posed to the audience was,
we replace injections by oral medications “Whether to continue with chloramphenicol
for severe pneumonia?” This randomized as the first line treatment for very severe
multi-center equivalency study, conducted pneumonia?” The Severe Pneumonia
by Amoxicillin Penicillin Pneumonia Evaluation Antimicrobial Research (SPEAR)
International Study (APPIS) group, included a study, a collaboration between Boston
sample size of 1702 children from nine study University, WHO and Johns Hopkins
sites (8 countries, 3 continents) to look into University, was an open label randomized
oral amoxicillin versus injectable penicillin controlled trial with 958 children from tertiary
for severe pneumonia in children aged care hospitals in seven countries.4 The study
3-59 months. The results showed an equal results showed more treatment failures with
treatment failure of 19% and 22% in both the chloramphenicol on day 5 as well as by days
groups at 48 hours and 5 days respectively. 10 and 21 and isolation of S. pneumoniae
Thus, the study concluded that injectable associated with increased risk of treatment
penicillin and oral amoxicillin are equivalent failure in the chloro-group on day 21,
for severe pneumonia treatment in controlled thus, concluding that injectable ampicillin
settings and there are certain potential plus gentamicin is superior to injectable
benefits of oral treatment when compared to chloramphenicol for community-acquired
injectables, like reduced risk of needle-borne pneumonia.
diseases, need for hospitalization and referral
costs. Summarising the findings from the studies,
Dr. Patwari concluded that there is a need
With regard to ambulatory treatment for for targeted research to improve ARI case
severe pneumonia, he mentioned that management guidelines and simultaneously
hospitalization and referrals are issues update current WHO guidelines for
of concern in India and in many of the management of severe pneumonia. The
developing countries. Apart from the growing resistance pattern of S. pneumoniae
difficulties faced in hospitalization and and the risk of treatment failures need
referral, risk of pneumococcal infection and to be seriously considered and evidence
even the inadequacy of the health system needs to be built to support switching
in providing needles and syringes are issues over from parenteral to oral therapy in
of concern. The study, “New Outpatient severe pneumonia. In addition, the risk of
Short-Course Home Oral Therapy for Severe hypoxaemia and need for oxygen therapy also
Pneumonia (NO-SHOTS)”3, published in need to be considered.
Lancet in 2008, looked at 2037 children, aged
3-59 months, with severe pneumonia at seven Preventing Severe Bacterial
study sites in Pakistan. The study concluded Pneumonia in South Asian Region
that home treatment with high dose oral
amoxicillin is equivalent to parenteral Dr. Kurien Thomas, Christian Medical
ampicillin for severe pneumonia without College, Vellore began his presentation by
underlying complications. highlighting the global and national burden
3
Hazir T, Fox LM, Nisar YB, Fox MP, Ashraf YP, MacLeod WB, et al. Ambulatory short-course high-dose oral amoxicillin for treatment
of severe pneumonia in children: a randomised equivalency trial. Lancet 2008; 371:49-56.
4
Asghar R, Banajeh S, Egas J, Hibberd P, Iqbal H, et al. Chloramphenicol versus ampicillin plus gentamicin for community acquired
very severe pneumonia among children aged 2-59 months in low resource settings: multicentre randomised controlled trial (SPEAR
study). BMJ 2008; 336: 80 - 84.
5
National Consultation on Childhood ARI Case Management: Translating Research to Policy and Program
5
World Health Organization. Pneumococcal conjugate vaccine for childhood immunization (WHO position paper). Weekly Epid.
Record 2006; 82: 93-104.
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Proceedings
In conclusion, Dr. Thomas cited the example enrolment, but relapse within the next 7 days
of Sri Lanka, where policy level changes have of observation with 3 days versus 5 days oral
been achieved by introducing pneumococcal amoxicillin therapy and also the proportions
conjugate vaccine in national program with who had resistant strains of S. pneumoniae or
much higher levels of penicillin resistance H. influenzae in NSP cultures on day 0 and 14.
and different serotype distribution. Raising
the context of India, he mentioned that The study was conducted in the context
Hib vaccine has been introduced in India, of cotrimoxazole being recommended as
primarily as a vaccine against meningitis in the first line drug for NSP under India’s ARI
children as part of Universal Immunization Control Programme, significant in vivo and
Program (UIP) in eight states from 2009. in-vitro resistance to cotrimoxazole being
While the National Technical Group on reported, and clinical studies showing
Immunization has recommended the high treatment failure with cotrimoxazole.
introduction of an appropriate conjugate Therefore, there was a need to switch to the
vaccine (PCV-10 or PCV-13), there is a need next recommended drug, amoxycillin. Since
to evaluate the operational issues associated the cost of treatment with amoxycillin is high,
with the introduction of the vaccine. the other option was to investigate whether
a shorter course of treatment would be as
Advances on the Treatment of effective as conventional treatment, as seen
Non-Severe Pneumonia (NSP) in cases of urinary tract infections. Inferring
from the study, Dr. Awasthi concluded that
In her presentation, Dr. Shally Awasthi, oral amoxicillin for three days is as effective
King George’s Medical University, Lucknow clinically as five days in the treatment of
chronologically shared results from three children 2-59 months old suffering from
studies. The first study, “ISCAP Study-Double NSP and in the nasopharyngeal isolates of
Blind, Placebo Controlled Trial of 3 Versus 5 S. pneumonia on days 12-14, an increase in
days’ Amoxicillin for Non-Severe Pneumonia in-vitro resistance to cotrimoxazole was seen
(NSP),” 6 compared the proportion of children with 5-day treatment.
(2-59 months) presenting with non-severe
pneumonia, who achieve clinical cure Dr. Awasthi next discussed a second study
on day 5 with 3 days versus 5 days of oral published in an online scientific journal
amoxicillin therapy. The study also compared PLoSONE titled, “Does Three-Day Course
the proportion of enrolled children who of Oral Amoxycillin Benefit Children of
were judged to be clinically cured on day 5 of Non-Severe Pneumonia with Wheeze: A
Multi-centric Randomised Control Trial?”
It was based on the rationale that the
current IMCI algorithm prescribes that
children with wheeze and fast breathing
that present to first level health facilities
should be given antibiotics if they continue
to have fast breathing, which is above the
age dependent respiratory rate cut-off of
WHO defined pneumonia, after two doses of
bronchodilator. While the primary purpose
of the algorithm is to prevent mortality
due to bacterial pneumonia, an unknown
6
ISCAP Study Group. Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a
multi-centre randomized controlled trial. BMJ 2004; 328:791.
7
National Consultation on Childhood ARI Case Management: Translating Research to Policy and Program
7
Awasthi S, Girdhar A, Singh JV, Kabra SK, Pillai RM, et al. Effectiveness of 3-Day Amoxicillin vs. 5-Day Cotrimoxazole in the
Treatment of Non-severe Pneumonia in Children Aged 2–59 Months of Age: A Multi-centric Open Labeled Trial. Journal of Tropical
Pediatrics 2008; 54(6):382-389.
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Proceedings
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National Consultation on Childhood ARI Case Management: Translating Research to Policy and Program
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Proceedings
delay in getting treatment is a major severe pneumonia. Till there is more India
constraint. specific data, treatment with injectables
b. Measles and pertussis immunization needs to be continued for severe pneumonia.
coverage rates need to be increased to Results from the IndiaCLEN’s multi-centric
levels that eliminate it as a public health Severe Pneumonia Oral Therapy (ISPOT)
threat. This is an unfinished agenda study on use of oral amoxicillin, currently
requiring greater rigor, and NRHM underway, may be useful, once available. Lady
provides an opportunity to strengthen Hardinge Medical College’s to-be-published
the health system to deliver the routine research on treatment with antibiotics in a
immunization programme. scenario of viral pneumonia will also provide
c. Additional vaccines such as Hib and important evidence in the treatment of
pneumococcal vaccine need to be severe pneumonia. For severe pneumonia,
reviewed with caution, and perhaps more the decision for the treatment drug should
evidence needs to be garnered before a be based on whether referral to a hospital is
policy decision can be made. possible or not. If referral is not possible, oral
d. We need to further explore the amoxicillin (high dose 80-90 mg/kg/day) for
relationship between ARIs and protein five days should be prescribed. If referral is
energy malnutrition, micronutrient feasible, injectable penicillin or ampicillin
deficiencies, exposure to smoke and should continue as drug of choice for severe
overcrowding, and equity and access to pneumonia. This is so because of paucity of
health services. evidence for home-based treatment of severe
pneumonia. Where referral is not possible, the
2. Recommendations related to ARI case capacity of the health worker needs to be built
management to recognize severe pneumonia and manage
a. Non-severe pneumonia the case. However, a caveat is that ANMs are
While there is evidence from tertiary care not allowed to administer amoxicillin and
settings, there is little information on thus, this would require a policy change.
the etiology and micro-organisms from
community settings. More information will c. Wheezing
need to be generated on the etiological agent Dr. Awasthi’s study provides good evidence
and anti-microbial susceptibility, and changes towards nebulization of children with
over time. Existing evidence does not greatly lower ARI. The feasibility of using spacing
support a change from cotrimoxazole to devices is not an issue; rather, the issue is
amoxicillin or any other antibiotic. Therefore, of capacity and acceptance of program,
status-quo should be maintained, while and empowerment of health worker. We
continuing to be vigilant and keeping the need to revise the protocol for wheezing
program and policy informed of the latest management in the IMNCI algorithm with
research developments. Research gaps need the need to incorporate wheezing box as
to be addressed by generating community- an essential equipment for facility settings.
based data. At the Primary Health Centre (PHC) level,
metered-dose inhalers with spacers should be
b. Severe pneumonia made available. Urgent feasibility studies are
There are two issues for discussion – whether required in community settings.
a short course can be given at the hospital,
and if these cases can be treated at home. 3. Role of ASHA in ARI case management
Short course seems an attractive proposition,
once the data is firm and defendable. Oral The issue of Accredited Social Health
therapy can be given for pneumonia, but not Activist (ASHA) being allowed to administer
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National Consultation on Childhood ARI Case Management: Translating Research to Policy and Program
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Proceedings
Dr. Reeta Rasaily from the Indian Council well-listed and ICMR would be happy to
of Medical Research (ICMR) pointed that support research activity in this regard. ICMR
the basic mandate of ICMR is to promote is in the process of having expert group
research in the country and provide useful meetings to finalize priorities to take up for
evidence for incorporation into the program. achieving MDG 4, and the recommendations
Pneumonia, with its high morbidity and very much fit into ICMR priorities. She
mortality burden, is a priority for ICMR. She concluded that ICMR welcomed research
indicated that the research priorities were proposals in this regard.
13
III.Next Steps on Taking the
Recommendations Forward
Dr. N.K. Arora pointed out that there is a need health policy are in the process of finalization;
to engage with the Ministry more closely to the deliberations from this consultation could
take the recommendations forward. A brief be incorporated in both.
document with rationale and justification can
be prepared as a background document and The consultation concluded with a synthesis
shared with the MoHFW. The development of the discussions by Dr. Vinod Paul, a vote
partners, researchers and academicians of thanks by Dr. Marta Levitt-Dayal, Chief
present in the meeting should contribute of Party, MCH-STAR, and presentation of
to that document. Two additional exciting partnership plaques to representatives from
opportunities are available for taking the IAP, ICMR, and Government of Uttar Pradesh
recommendations to policy and program. The on behalf of IndiaCLEN, MCH-STAR and
adaptation group of IMNCI and draft child USAID.
14
Annex 1
IV. Agenda
National Consultation on
Childhood ARI Case Management: Translating Research to Policy
and Programme
Chair:
Dr.Vijay Kumar, WHO/SEARO
Moderator:
Dr. Rajiv Tandon, USAID
Presenters:
Dr. Ashok Patwari, Boston University
Dr. Kurien Thomas, IndiaCLEN
Dr. Shally Awasthi, IndiaCLEN
Dr. N.K. Arora, IndiaCLEN
11:45 am – 1:30 pm Panel Discussion: Translating Research Findings to Policy and
Programme
Moderator:
Dr Vinod Paul, AIIMS
Panelists:
Dr. Sangeeta Saxena, MoHFW, Government of India
Dr. Panna Choudhury, IAP
Dr. Reeta Rasaily, ICMR
Dr. Vijay Kumar, WHO/SEARO
Dr. N.K. Arora, IndiaCLEN
1:30 pm Vote of thanks, Dr. Marta Levitt-Dayal, MCH-STAR
1:40 pm onwards LUNCH
15
Annex 2
V. Participants
National Consultation on
Childhood ARI Case Management: Translating Research to Policy and Program
List of Participants
16
Participants
17
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