Evidence map›Paper›PMID 30940760›Full record

ArticleBMJ open2019

AMBIsome Therapy Induction OptimisatioN (AMBITION): High dose AmBisome for cryptococcal meningitis induction therapy in sub-Saharan Africa: economic evaluation protocol for a randomised controlled trial-based equivalence study.

Ponego Lloyd Ponatshego, David Stephen Lawrence, Nabila Youssouf, Sile F Molloy, Melanie Alufandika, Funeka Bango, David R Boulware, Chimwemwe Chawinga, Eltas Dziwani, Ebbie Gondwe and 28 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

38 authors at 11 institutions in 8 countries.

Ponego Lloyd Ponatshego *Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
David Stephen Lawrence *Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
Nabila YoussoufBotswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
Sile F MolloyResearch Centre for Infection and Immunity, St. George's University of London, London, UK.
Melanie AlufandikaMalawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.
Funeka BangoInstitute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
David R BoulwareInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Chimwemwe ChawingaLilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.
Eltas DziwaniMalawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.
Ebbie GondweMalawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.
Admire HlupeniDepartment of Medicine, University of Zimbabwe, Harare, Zimbabwe.
Mina C HosseinipourLilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.
Cecilia KanyamaLilongwe Medical Relief Trust (UNC Project), Lilongwe, Malawi.
David B MeyaInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Mosepele MosepeleBotswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
Charles MuthogaBotswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
Conrad K MuzooraInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Henry MwandumbaMalawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.
Chiratidzo E NdhlovuDepartment of Medicine, University of Zimbabwe, Harare, Zimbabwe.
Radha RajasinghamDepartment of Medicine, University of Minnesota, Minnesota, USA.
Sumaya SayedInstitute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Shepherd ShamuDepartment of Medicine, University of Zimbabwe, Harare, Zimbabwe.
Katlego TsholoBotswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
Lillian TugumeInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Darlisha WilliamsInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Hendramoorthy MaheswaranMalawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.
Tinevimbo ShiriDepartment of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
Timothée Boyer-ChammardMolecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.ORCID 0000-0003-3399-0808
Angela LoyseResearch Centre for Infection and Immunity, St. George's University of London, London, UK.
Tao ChenDepartment of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
Duolao WangDepartment of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
Olivier LortholaryMolecular Mycology Unit and National Reference Centre for Invasive Mycoses, Institut Pasteur, Paris, France.
David G LallooMalawi-Liverpool-Wellcome Trust Clinical Research Centre, Blantyre, Malawi.
Graeme MeintjesInstitute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Shabbar JaffarDepartment of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
Thomas S HarrisonResearch Centre for Infection and Immunity, St. George's University of London, London, UK.
Joseph N Jarvis *Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
Louis Wilhelmus Niessen *Department of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
University of Liverpool · GBLiverpool School of Tropical Medicine · GBBotswana Harvard AIDS Institute Partnership · BWInfectious Diseases Institute · UGLondon School of Hygiene & Tropical Medicine · GBSt George's, University of London · GBUniversity of Cape Town · ZAUniversity of Minnesota · USUniversity of Zimbabwe · ZWInstitut Pasteur · FRUniversity of Botswana · BW

Funding

Malawi HIV Implementation Research Scientist Training Program (MHIRST)D43TW010060 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MINA CHRISTINE HOSSEINIPOUR, Victor Mwapasa · 2015 to 2026
$3.8M
Evaluation of CRAG screening with enhanced antifungal therapy for asymptomatic CRAG-positive personsK23AI138851 · NIAID · UNIVERSITY OF MINNESOTA · PI RAJASINGHAM, RADHA · 2018 to 2022
$954k
FIC NIH HHS D43 TW010060Medical Research Council MC_PC_MR/P006922/1NIAID NIH HHS K23 AI138851Wellcome Trust
6 · The paper itself

Abstract

introductionCryptococcal meningitis is responsible for around 15% of all HIV-related deaths globally. Conventional treatment courses with amphotericin B require prolonged hospitalisation and are associated with multiple toxicities and poor outcomes. A phase II study has shown that a single high dose of liposomal amphotericin may be comparable to standard treatment. We propose a phase III clinical endpoint trial comparing single, high-dose liposomal amphotericin with the WHO recommended first-line treatment at six sites across five counties. An economic analysis is essential to support wide-scale implementation. METHODS AND ANALYSIS: Country-specific economic evaluation tools will be developed across the five country settings. Details of patient and household out-of-pocket expenses and any catastrophic healthcare expenditure incurred will be collected via interviews from trial patients. Health service patient costs and related household expenditure in both arms will be compared over the trial period in a probabilistic approach, using Monte Carlo bootstrapping methods. Costing information and number of life-years survived will be used as the input to a decision-analytic model to assess the cost-effectiveness of a single, high-dose liposomal amphotericin to the standard treatment. In addition, these results will be compared with a historical cohort from another clinical trial. ETHICS AND DISSEMINATION: The AMBIsome Therapy Induction OptimisatioN (AMBITION) trial has been evaluated and approved by the London School of Hygiene and Tropical Medicine, University of Botswana, Malawi National Health Sciences, University of Cape Town, Mulago Hospital and Zimbabwe Medical Research Council research ethics committees. All participants will provide written informed consent or if lacking capacity will have consent provided by a proxy. The findings of this economic analysis, part of the AMBITION trial, will be disseminated through peer-reviewed publications and at international and country-level policy meetings.

trial registrationISRCTN 7250 9687; Pre-results.

Indexed as

Amphotericin BDrug CostsHealth ExpendituresMeningitis, CryptococcalAfrica South of the SaharaAntifungal AgentsClinical Trials, Phase III as TopicCost-Benefit AnalysisDose-Response Relationship, DrugDrug Administration ScheduleEquivalence Trials as TopicFollow-Up StudiesHumansProspective StudiesRandomized Controlled Trials as TopicAmphotericin BAntifungal Agentsliposomal amphotericin Bclinical trialscryptococcal meningitishealth economicstropical medicine

Identifiers

PMID30940760
PMCPMC6500286
OpenAlexW2934273482

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.