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Community-Acquired InfectionsCABSYNCNCT02946775

Community Acquired Bacteremic Syndromes in Young Nigerian Children

An observational study of Community-Acquired Infections, run by University of Nebraska at 1 site in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To define the etiologic agents of community acquired bacteremic syndromes (defined as septicemia, bacteremia, pneumonia and/or meningitis) in a malaria endemic setting. Read more about this study

Who is it for?
Ages 1 minute to 14 years
Conditions the study is for
Community-Acquired Infections
How many people
29,146 participants
Where
1 siteNigeria
Study dates
13 Sep 2012to 1 Jul 2018
Phase
Observational
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 1 minute to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric subjects 0-14 years of age

Who may be able to join

  • Children 0-14 years of age presenting with an acute febrile illness with a temperature of more than or equal to 38 degrees C or hypothermia (temperature less than 36 degrees C) with any of the following symptoms; convulsion, respiratory distress, prostration or non-traumatic circulatory collapse to the pediatric outpatient or emergency pediatric units of participating Nigerian institutions.

Who cannot join

  • No consent obtained/withdrawal of consent, known congenital heart disease, bronchial asthma, or recent hospitalizations within the past 2 weeks.

Trial locations and contacts

1 site in 1 country.

Nigeria1 site
  • Nigerian health clinics

    Abuja

Other trials in Nigeria

About this study

To define the etiologic agents of community acquired bacteremic syndromes (defined as septicemia, bacteremia, pneumonia and/or meningitis) in a malaria endemic setting.

Read the detailed description

Specific Aim 1. To define and characterize the etiologic agents of community acquired bacteremic syndromes in young Nigerian children Hypothesis 1a: the role of vaccine-preventable infections such as those caused by the Pneumococcus, Hib in the etiology of CABS is currently underestimated due to widespread use of non-prescription antibiotics. Hypothesis 1b: Salmonella species are the leading cause of persistent febrile illness (fever > 2 weeks) in young Nigerian children.

Specific Aim 2. To determine the role of respiratory viruses in promoting the severity of bacteremic and radio-logic pneumonia Hypothesis 2: Influenza viruses promote the severity of bacteremic pneumonia

Specific Aim 3. To determine acute host inflammatory response profiles in CABS associated with respiratory distress Hypothesis 3a: Bacteremia induces a pattern of host inflammatory profile that is distinct from those induced by malaria or respiratory viral infections. Hypothesis 3b: Clinical presentation and outcome (death, survival or prolonged hospitalization) is associated with pro-inflammatory and anti-inflammatory cytokine and chemokine dissonance.

The global burden of childhood deaths is largely borne by developing countries. Of the estimated 10 million deaths that occur in children aged less than 5 years, over 90% of these occur in developing countries and more than half of these in sub Saharan Africa. Causes of these deaths have been largely classified based on syndrome presentation, such as pneumonia, malaria, diarrhea, meningitis and septicemia and only recently have attempts been made to define the etiologic pathogens that are responsible for these deaths, an important step to implementing primary prevention. In sub Saharan Africa, malaria has for a long time been perceived as the leading cause of childhood deaths but recent studies from Kenya suggest that more deaths are in fact caused by bacteremia. However, disease burden varies by region and disease burden perceptions also vary, particularly in malaria endemic regions where clinical presentation of acute malaria, pneumonia and sepsis are often indistinguishable. The situation is compounded further in regions where malaria is present all-year round where children who are bacteremic may also have malaria parasitemia and healthy children may have asymptomatic parasitemia. These complex and overlapping features present a challenge for efficient clinical management and implementation of appropriate preventive measures.

In most developing countries, due to lack of local data, clinical management recommendations are often obtained from the World Health Organization for common conditions based on the integrated management of childhood illness approach 3. In such settings, diagnosis is based on a limited number of clinical syndromes. However, because seriously ill children often meet criteria for several clinical syndromes, each of which could be caused by several viral or bacterial pathogens, treatment is empiric and management approach is non-specific. A key component of clinical management in malaria endemic areas with high incidence of invasive bacterial disease is the initiation of antibiotic treatment and anti-malarials. While this approach provides an easy scheme, because it is not pathogen-specific there is a significant risk of promoting long-term antibiotic resistance due to over prescription of antibiotics and paradoxically, there is also the risk of increased mortality and morbidity due to inappropriate medication. An etiology-based management approach would be more effective and also provide data to explore primary preventive measures such as immunization.

Causes of bacteremia vary from reports in several sub-Saharan countries with high under-five childhood mortality. These include studies from Malawi and the Central African Republic where Non-typhoidal Salmonella (NTS) predominate and some reports from Nigeria where staphylococcus aureus has been the leading cause of bacteremia in young children.

There are only a few studies from Nigeria, the most populated country in sub-Saharan Africa, and these studies have not identified S. pneumoniae nor Hib as an important pathogen in the etiology of community acquired bacteremic illness or invasive bacterial disease in young children. The disparity in prevalence of different bacterial pathogens across countries is likely due to the different study entry criteria, age groups, bacterial culture methods and the prevalence of antibiotic exposure in the population. A high rate of antibiotic use is likely to select for resistant bacterial strains in such populations. It is notable that of all the studies that identified S. pneumoniae as a leading cause of bacteremia were studies that utilized the automated Bactec culture system. Thus to determine the true burden of vaccine-preventable bacterial disease in such a setting would warrant the use of culture-based and molecular microbiology techniques that would overcome the problem of poor sensitivity secondary to partially treated infections.

Of the childhood illnesses commonly associated with bacteremia, pneumonia is the leading cause of death, with Streptococcus pneumonia making a significant contribution to these deaths in reports from the Gambia but limited data from the West African sub region. Thus this study will focus on providing further understanding of the etiologic agents of bacteremia and pneumonia. Determination of the cause of pneumonia remains a challenge, since bacterial blood culture, the current "gold standard" is useful only when when pneumonia is associated with bacteremia and is positive only in about 10-15% of cases. The vast majority of pneumonias are not associated with bacteremia and to ascertain cause in these cases warrants the use of lung aspirates, a very specific but invasive procedure used only in research settings.

When a clinical diagnosis of pneumonia is made using the WHO guideline, which is very sensitive but poorly specific, only a fraction of these have any radio-logic abnormality and a variable smaller fraction still, have a confluent alveolar density that culminates in a lobar consolidation. When the lung consolidation is readily assessable to the chest wall, the more sensitive and specific approach for the etiologic diagnosis is the use of a percutaneous lung aspirate which is considered invasive and only used in research settings. This approach improved etiologic diagnosis from 18% with the use of blood culture alone to 52%. Since this procedure is invasive and reserved for only selected cases, the causes of most non-bacteremic pneumonia remains poorly defined.

At the population level, another approach for determining the burden of disease-attributable to an etiologic agent in a population is the use of an efficacious vaccine. For example, in The Gambia, the pneumococcal conjugate vaccine efficacy trial was associated with 37% reduction in radio-logic pneumonia and 16% reduction in all-cause childhood mortality; an important testament to the under-estimation of the true disease burden attributable to the pneumococcus and the poor sensitivity of the current diagnostic methods for the detection of invasive pneumococcal disease in young children. While the development and application of these new generation vaccines are a major advancement with a huge potential for saving several thousands of lives, they also provide a sensitive tool for probing the burden of vaccine-attributable preventable disease in a population but are very expensive.

The determination of the causes of pneumonia in childhood presents a further challenge as other agents such as viruses have often been identified from respiratory secretions but their role in the patho-genesis of severe pneumonia in developing countries is less well defined.

Understanding the host immune responses to infection is critical to providing insight into treatment modalities, since these responses and not necessarily the pathogen, determine outcome. This observation is further supported by the observation that prompt diagnosis and initiation of antibiotic treatment does not always avert death as recently reported from a study from the Gambia, where delayed mortality was reported within 28 days of hospital discharge after appropriate in-patient care at a hospital. The reason for these delayed deaths is unknown but prolonged immunologic dissonance (imbalance between pro-inflammatory and anti-inflammatory cytokines) is a likely contributing factor. This deserves further investigation since if these delayed deaths are due to immunologic dissonance, these deaths may be averted with the use of steroids or other immunomodulators, in addition to antibiotics. Characterization of host inflammatory responses among children with community acquired pneumonia may facilitate understanding of host inflammatory response, provide a prognostic tool for clinicians or identify potential therapeutic targets.

Children presenting with an acute febrile illness, with respiratory distress in a malaria endemic region may have severe malaria, bacteremia, sepsis and/or pneumonia. A number of studies have explored acute inflammatory markers such as C-reactive protein and procalcitonin but have reported significant overlap in serum concentration of these proteins in both conditions to justify a diagnostic use for in such settings. While the clinical presentation with respiratory distress in pneumonia and malaria may be similar, understanding the molecular basis for this clinical sign could provide valuable information for diagnosis and treatment.

In summary, community acquired bacteremic syndromes in malaria endemic regions of Africa presents a diagnostic conundrum for physicians and pose an important clinical management dilemma that warrants further evaluation. This study proposes to take advantage of new molecular and genomic technology in addressing this challenge with the ultimate goal of defining the etiologic agents of community acquired bacteremic syndromes in Nigerian children and generating information on host inflammatory responses that would be useful in developing primary and secondary preventative measures.

Keywords
septicemia, bacteremia, pneumonia, meningitis
Medical subject headings
Community-Acquired Infections, Sepsis, Bacteremia, Pneumonia, Meningitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bacterial infections in children

    Prevalence of bacterial infections in children identified through analysis of blood culture.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study start13 Sep 2012
  3. Primary completion1 Jul 2018
  4. Study completion1 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
29,146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02946775
Sponsor's protocol ID
0444-12 EP
Acronym
CABSYNC
Status last verified
Sep 2023
First submitted
1 Dec 2014
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Community-Acquired Infections, run by University of Nebraska at 1 site in Nigeria.

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 1 inclusion and 1 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nigeria. 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?

Bacterial infections in children (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Sep 2023.

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