Evidence map›Paper›PMID 38491528›Full record

Trial reportParasites & vectors2024

Onchocerca volvulus microfilariae in the anterior chambers of the eye and ocular adverse events after a single dose of 8 mg moxidectin or 150 µg/kg ivermectin: results of a randomized double-blind Phase 3 trial in the Democratic Republic of the Congo, Ghana and Liberia.

Eric M Kanza, Amos Nyathirombo, Jemmah P Larbelee, Nicholas O Opoku, Didier K Bakajika, Hayford M Howard, Germain L Mambandu, Maurice M Nigo, Deogratias Ucima Wonyarossi, Françoise Ngave and 10 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Parasites & vectors, 2024. 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
1.6field-weighted citation impact, top 19% 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, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  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

20 authors at 12 institutions in 11 countries.

Eric M Kanza *Centre de Recherche Clinique de Butembo, Université Catholique du Graben, Site Horizon, Butembo, Nord Kivu, Democratic Republic of the Congo.
Amos Nyathirombo *Centre de Recherche en Maladies Tropicale de L'Ituri, Hôpital Générale de Référence de Rethy, Ituri, Democratic Republic of the Congo.
Jemmah P Larbelee *Clinical Research Center, Liberia Institute for Biomedical Research, Bolahun, Liberia.
Nicholas O OpokuOnchocerciasis Chemotherapy Research Center, Hohoe, Ghana.
Didier K BakajikaCentre de Recherche en Maladies Tropicale de L'Ituri, Hôpital Générale de Référence de Rethy, Ituri, Democratic Republic of the Congo.
Hayford M HowardClinical Research Center, Liberia Institute for Biomedical Research, Bolahun, Liberia.
Germain L MambanduCentre de Recherche en Maladies Tropicale de L'Ituri, Hôpital Générale de Référence de Rethy, Ituri, Democratic Republic of the Congo.
Maurice M NigoCentre de Recherche en Maladies Tropicale de L'Ituri, Hôpital Générale de Référence de Rethy, Ituri, Democratic Republic of the Congo.
Deogratias Ucima WonyarossiCentre de Recherche en Maladies Tropicale de L'Ituri, Hôpital Générale de Référence de Rethy, Ituri, Democratic Republic of the Congo.
Françoise NgaveCentre de Recherche en Maladies Tropicale de L'Ituri, Hôpital Générale de Référence de Rethy, Ituri, Democratic Republic of the Congo.
Kambale Kasonia KennedyCentre de Recherche Clinique de Butembo, Université Catholique du Graben, Site Horizon, Butembo, Nord Kivu, Democratic Republic of the Congo.
Kambale KatalikoCentre de Recherche en Maladies Tropicale de L'Ituri, Hôpital Générale de Référence de Rethy, Ituri, Democratic Republic of the Congo.
Kpehe M BolayClinical Research Center, Liberia Institute for Biomedical Research, Bolahun, Liberia.
Simon K AttahOnchocerciasis Chemotherapy Research Center, Hohoe, Ghana.
George OlipohOnchocerciasis Chemotherapy Research Center, Hohoe, Ghana.
Sampson AsareOnchocerciasis Chemotherapy Research Center, Hohoe, Ghana.
Mupenzi MumbereCentre de Recherche Clinique de Butembo, Université Catholique du Graben, Site Horizon, Butembo, Nord Kivu, Democratic Republic of the Congo.
Michel VaillantCompetence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Grand Duchy of Luxembourg.
Christine M HalleuxUNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR), World Health Organization, Geneva, Switzerland.
Annette C KueselUNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR), World Health Organization, Geneva, Switzerland. kuesela@who.int.ORCID http://orcid.org/0000-0002-1696-1784
Kinshasa General Hospital · CDLiberian Institute for Biomedical Research · LRWorld Health Organization · CHCenter for Global Development · USGulu University · UGLondon School of Hygiene & Tropical Medicine · GBLuxembourg Institute of Health · LUNational Assembly · KRUniversité Catholique du Graben · CDUniversity of Ghana · GHUniversity of Health and Allied Sciences · GHWind Power Engineering (Japan) · JP

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundAfter ivermectin became available, diethylcarbamazine (DEC) use was discontinued because of severe adverse reactions, including ocular reactions, in individuals with high Onchocerca volvulus microfilaridermia (microfilariae/mg skin, SmfD). Assuming long-term ivermectin use led to < 5 SmfD with little or no eye involvement, DEC + ivermectin + albendazole treatment a few months after ivermectin was proposed. In 2018, the US FDA approved moxidectin for treatment of O. volvulus infection. The Phase 3 study evaluated SmfD, microfilariae in the anterior chamber (mfAC) and adverse events (AEs) in ivermectin-naïve individuals with ≥ 10 SmfD after 8 mg moxidectin (n = 978) or 150 µg/kg ivermectin (n = 494) treatment.

methodsWe analyzed the data from 1463 participants with both eyes evaluated using six (0, 1-5, 6-10, 11-20, 21-40, > 40) mfAC and three pre-treatment (< 20, 20 to < 50, ≥ 50) and post-treatment (0, > 0-5, > 5) SmfD categories. A linear mixed model evaluated factors and covariates impacting mfAC levels. Ocular AEs were summarized by type and start post-treatment. Logistic models evaluated factors and covariates impacting the risk for ocular AEs.

resultsMoxidectin and ivermectin had the same effect on mfAC levels. These increased from pre-treatment to Day 4 and Month 1 in 20% and 16% of participants, respectively. Six and 12 months post-treatment, mfAC were detected in ≈5% and ≈3% of participants, respectively. Ocular Mazzotti reactions occurred in 12.4% of moxidectin- and 10.2% of ivermectin-treated participants without difference in type or severity. The risk for ≥ 1 ocular Mazzotti reaction increased for women (OR 1.537, 95% CI 1.096-2.157) and with mfAC levels pre- and 4 days post-treatment (OR 0: > 10 mfAC 2.704, 95% CI 1.27-5.749 and 1.619, 95% CI 0.80-3.280, respectively).

conclusionsThe impact of SmfD and mfAC levels before and early after treatment on ocular AEs needs to be better understood before making decisions on the risk-benefit of strategies including DEC. Such decisions should take into account interindividual variability in SmfD, mfAC levels and treatment response and risks to even a small percentage of individuals.

Indexed as

Intestinal VolvulusMacrolidesOnchocerca volvulusOnchocerciasisAnimalsAnterior ChamberDemocratic Republic of the CongoDouble-Blind MethodFemaleGhanaHumansIvermectinLiberiaMaleMicrofilariaeOnchocercaIvermectinMacrolidesmoxidectinDiethylcarbamazineIncrease in ocular microfilariaeIvermectinMicrofilariae in the anterior chamberMicrofilariae mobilizationMoxidectinOcular adverse eventsOcular Mazzotti reactionsOcular microfilariaeOnchocerciasis

Identifiers

PMID38491528
PMCPMC10943894
OpenAlexW4392865151

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.