Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Mar 7:11:04016.
doi: 10.7189/jogh.11.04016.

Malawian children with chest-indrawing pneumonia with and without comorbidities or danger signs

Amy Sarah Ginsburg  1 , Tisungane Mvalo  2 , Melda Phiri  2 , Daphne Gadama  2 , Claightone Chirombo  2 , Madalitso Maliwichi  2 , Jun Hwang  1 , Susanne May  1
Affiliations
Randomized Controlled Trial

Malawian children with chest-indrawing pneumonia with and without comorbidities or danger signs

Amy Sarah Ginsburg et al. J Glob Health. .

Abstract

Background: Children with comorbidities or danger signs are often excluded from trials evaluating pneumonia treatment.

Methods: We sought to investigate whether the percentage of children with chest-indrawing pneumonia cured at Day 14 was lower among those with HIV infection or exposure, malaria, moderate or severe acute malnutrition, or anemia enrolled in a prospective observational cohort study than among children without these comorbidities enrolled in a concurrent prospective randomized controlled trial evaluating duration of amoxicillin treatment in Lilongwe, Malawi.

Results: Children with chest-indrawing pneumonia and comorbidities but without danger signs did not have statistically significant higher treatment failure rates by Day 6 than those in the chest-indrawing pneumonia clinical trial. However, children with chest-indrawing pneumonia and HIV infection or exposure, malaria, or moderate or severe acute malnutrition had higher rates of not being clinically cured at Day 14 when compared to children without these comorbidities (adjusted differences ranging from 7.7% to 17.0%). Furthermore, among children without danger signs at enrollment, but with HIV infection or HIV exposure or moderate or severe acute malnutrition, 12.5% and 15.6% respectively were not clinically cured at Day 14 even though they were without treatment failure by Day 6.

Conclusions: More intensive follow-up of children with chest-indrawing pneumonia and comorbidities who do not have danger signs may be beneficial.

PubMed Disclaimer

Conflict of interest statement

Competing interests: The authors completed the ICMJE Unified Competing Interest form (available upon request from the corresponding author), and declare no conflicts of interest.

Figures

Figure 1
Figure 1
ITIP3 chest-indrawing pneumonia cohort enrollment by comorbidities. *Subgroups are based on data from screening/enrollment form. †Danger signs defined as one of more of the following: lethargy or unconsciousness, convulsions, vomiting everything, inability to drink or feed, grunting, nasal flaring, and/or head nodding. ‡Major comorbidity defined as 1 or more of the following: HIV: positive HIV-1 rapid diagnostic test or HIV exposure; Malaria: positive malaria rapid diagnostic test with or without any danger signs, stiff neck, abnormal bleeding, clinical jaundice, or hemoglobinuria; Malnutrition: mid-upper arm circumference <12.5 cm or weight-for-height z-score<-2; Anemia: hemoglobin <8 g/dL.
Figure 2
Figure 2
Treatment failure status (yes = gray/ no = white) by Day 6 and clinically cured status (no = gray/ yes = white) by Day 14 for pre-selected comorbidities (HIV infection or exposure; moderate or severe acute malnutrition; malaria; and anemia) stratified by whether (w) or not (wo) children presented with danger signs (DS)
See this image and copyright information in PMC

References

    1. Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, et al. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015;385:430-40. 10.1016/S0140-6736(14)61698-6 - DOI - PubMed
    1. UNICEF Pneumonia. Available: https://data.unicef.org/topic/child-health/pneumonia/. Accessed: 2 October 2020.
    1. Ginsburg AS, May SJ, Nkwopara E, Ambler G, McCollum ED, Mvalo T, et al. Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol. BMC Infect Dis. 2018;18:476. 10.1186/s12879-018-3379-z - DOI - PMC - PubMed
    1. Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Phiri M, Schmicker R, et al. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020;383:13-23. 10.1056/NEJMoa1912400 - DOI - PMC - PubMed
    1. Ginsburg AS, May S, Nkwopara E, Ambler G, McCollum ED, Mvalo T, et al. Clinical Outcomes of Pneumonia and Other Comorbidities in Children Aged 2-59 Months in Lilongwe, Malawi: Protocol for the Prospective Observational Study “Innovative Treatments in Pneumonia”. JMIR Res Protoc. 2019;8:e13377. 10.2196/13377 - DOI - PMC - PubMed

Publication types