Publications

Funding for clinical research |drugs, vaccines, microbicides, diagnostics | HIV/AIDS, tuberculosis, malaria, other infectious diseases |sub-Saharan Africa

EDCTP portfolio: Neglected infectious diseases

The BabyGel study is examining whether giving mothers an alcohol-based hand rub can reduce severe infections in newborns.

Preventing neonatal infection with hand rub

Infections account for an estimated 26% of neonatal deaths. Around 750,000 newborns die each year, and neonatal mortality is highest in sub-Saharan Africa, where nearly half of all deaths of children under five years occur. The annual economic burden attributable to severe neonatal infections could be as high as US$469 B.

Simple water, sanitation and hygiene interventions could dramatically cut infections rates, if widely adopted.

The challenge

The BabyGel study is exploring whether giving pregnant women alcohol-based hand rub for household use after they have given birth helps to reduce the risk of severe infections in the first three months of life. A pilot study has already shown that BabyGel alcohol-based hand rub could be distributed to women, was widely used and was safe.

The trial is taking place in rural Uganda. Expectant mothers will be given a BabyGel kit including five litres of perfumed alcohol-based hand rub, two dispensers and information about when to use it, emphasising the three key moments of neonatal hand hygiene (before touching baby, for initial cord care and after known risk exposures such as using the toilet).

Expectant mothers will receive the BabyGel kit in addition to a standard birthing kit and antenatal education. The trial will examine if provision of BabyGel has an impact on severe infant illness or death in the first 90 days of life, or on diarrhoeal disease and lower respiratory tract infections.

The project

The BabyGel study will determine the impact of a simple and widely implementable hygiene intervention that could reduce one of the leading causes of infant death in sub-Saharan Africa. Alcohol-based hand rub is cheap to produce locally, active against a wide range of infectious organisms, and easier to use than soap and water.

Impact


test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Infections account for an estimated 26% of neonatal deaths. Around 750,000 newborns die each year, and neonatal mortality is highest in sub-Saharan Africa, where nearly half of all deaths of children under five years occur. The annual economic burden attributable to severe neonatal infections could be as high as US$469 B.

Simple water, sanitation and hygiene interventions could dramatically cut infections rates, if widely adopted.

The BabyGel study is exploring whether giving pregnant women alcohol-based hand rub for household use after they have given birth helps to reduce the risk of severe infections in the first three months of life. A pilot study has already shown that BabyGel alcohol-based hand rub could be distributed to women, was widely used and was safe.

The trial is taking place in rural Uganda. Expectant mothers will be given a BabyGel kit including five litres of perfumed alcohol-based hand rub, two dispensers and information about when to use it, emphasising the three key moments of neonatal hand hygiene (before touching baby, for initial cord care and after known risk exposures such as using the toilet).

Expectant mothers will receive the BabyGel kit in addition to a standard birthing kit and antenatal education. The trial will examine if provision of BabyGel has an impact on severe infant illness or death in the first 90 days of life, or on diarrhoeal disease and lower respiratory tract infections.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

The BabyGel study will determine the impact of a simple and widely implementable hygiene intervention that could reduce one of the leading causes of infant death in sub-Saharan Africa. Alcohol-based hand rub is cheap to produce locally, active against a wide range of infectious organisms, and easier to use than soap and water.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M